Category Archives: Medical

Medex Cardio-Pulmonary Recalls Sterile Saline and Sterile Water

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death

Recalled Product(s):

  • Select serial and lot numbers of Smiths Medical Sterile Saline and Water (listed below)
  • Manufacturing Dates: August 30, 2013, to February 10, 2017
  • Distribution Dates: August 30, 2013, to February 10, 2017
  • Full list of affected devices
  • Devices Recalled in the U.S.: 939,364

Device Use

The sterile saline and water are respiratory humidification products used in patients undergoing respiratory therapy, tracheal wash, or wound cleaning.

Reason for Recall

Smiths Medical is recalling the sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents (bacillus infantis and staphylococcus epidermidis) because of damage to the containers used to package the finished products. Use of these products in patients could result in infection and may require treatment with antibiotics. Serious or untreated infections could result in patient death.

The company initiated a voluntary recall on September 5, 2017. That recall covered several products, including some that are outside the scope of this notice. The FDA is auditing the recall to ensure the company has notified all affected customers and that affected product has been returned. Based on the available information, the FDA is now classifying the action regarding the affected products (listed below) as a Class I recall.

Who May be Affected

  • Hospitals and health care professionals using Smiths Medical Sterile Saline or Water distributed from August 30, 2013, to February 10, 2017.
  • Patients receiving respiratory therapy or tracheal lavage with Smiths Medical Sterile Saline or Water distributed from August 30, 2013, to February 10, 2017.

What to Do

On September 5, 2017, Smiths Medical sent affected customers an “Urgent Medical Device Recall Notice” informing them of affected sterile water and saline product models and directing them to locate, determine the affected sterile saline or water products in their possession, and to complete the “Urgent Medical Device Recall Response Form” attached to the recall notice. Customers were also instructed to return all affected product to Stericycle for processing.

On January 7, 2019, distributer Medline Industries Inc. initiated a sub-recall for privately labeled product models and lots, affected by the September 5, 2017, Smiths Medical recall notice, that were not expired and which may be potentially contaminated with the infectious agents.

The notice asked customers to:

  1. Locate the affected Sterile Water, Saline and Eye Wash in their possession by referring to the specific model and lot numbers listed in the Urgent Medical Device Field Recall Response Form.
  2. Determine the number of affected devices in their possession and complete the Urgent Medical Device Field Recall Response Form attached to this letter within 10 days of receipt and send it to smithsmedicalste00100@stericycle.com. The form must be returned even if customers do not have any of the affected Sterile Water, Saline and Eye Wash in their possession. Product credit will be processed once the Urgent Medical Device Field Recall Response Form and affected product is received. All affected devices must be returned to Stericycle for processing. Pre‐paid shipping labels were included with the Urgent Medical Device Recall Notice.
  3. Package the affected devices and include a copy of the completed Urgent Medical Device Field Recall Response Form inside EACH BOX of the returned devices to obtain credit for the returned devices. Make sure boxes are sealed and labeled with the facility name prior to shipping devices to Stericycle.

Distributors are asked to immediately notify customers who received the affected product of this Recall.

Contact Information

Customers with questions regarding this notification may contact Stericycle via email at smithsmedicalste00100@stericycle.com.

Date Recall Initiated

September 5, 2017

Full List of Affected Devices

  • Portex 350 ml Sterile Water Humidifier w/5psi Adapt (Model # 352 Lot Numbers: A214, A215, Z263, Z532, and Z555)
  • Portex 550 ml Sterile Water Humidifier w/5psi Adapt (Model # 552 Lot Numbers: A054, A089, A090, and Z262)
  • Portex 1000 ml Sterile Water USP Pour Bottle (Model # 1065 Lot Numbers: B209 and Z225)
  • Portex 500 ml Sterile Water USP Pour Bottle (Model # 1565 Lot Number: Y371)
  • Intermed 350 ml Sterile Water Humidifier w/5psi Adapt. (Model # 0352IMJ Lot Numbers: A457, A597, B157, B236, Z589, Z655, Z656, and Z661)
  • Portex 550 ml Sterile Water Humidifier w/5psi Adapt. (Model # 0552C Lot Number: Z370)
  • Intermed 550 ml Sterile Water Humidifier w/5psi Adapt. (Model # 0552IMJ Lot Numbers: Z588 and Z597)
  • Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt. (Model # HCS00300 Lot Number: Y576)
  • Medline Prefilled 350 ml Sterile Water (Model # HCS00350 Lot Numbers: A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554)
  • Portex Unit Dose 5 ml Normal Saline (0.9%) (Model # R0059 Lot Number: B360), K820227
  • Portex Unit Dose 15 ml Normal Saline (Model # R0159 Lot Numbers: A661, B067, A526, A536, A569, and B201)
  • Portex 5ml Normal Saline (0.9%) Unit Dose (Model # UD9005 Lot Number: B515), K820227
  • Medline Prefilled 550 ml Sterile Water (Model # HCS00550 Lot Numbers: A092, B205, B534, and Z205)

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops

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Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1 To date, no serious adverse events have been reported related to this recall.

The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles. This voluntarily recall includes the six (6) lots listed below:

Lot No. NDC EXPIRATION DESCRIPTION COMPANY
4718 59779-925-23 12/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle CVS Pharmacy
00717005A 49035-125-24 02/19 Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle Wal-Mart Stores Inc.
00717006A 59779-925-24 

(Labeled as: 50428-1252-4)

 02/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle CVS Pharmacy
00717009A
(Previously announced) 		49035-125-23 02/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
00717015A
(Previously announced) 		49035-125-23 04/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
00717024A
(Previously announced) 		49035-125-23 08/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc
59779-925-23 CVS Health: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle		 CVS Pharmacy
55319-250-23 Family Wellness: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle		 Family Dollar Services Inc.

Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. The retailers should stop further distribution of the affected lots, which are being recalled. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors.

Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com. Consumers, who may be concerned, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). The FDA has approved a class II retail level recall for this recall,

Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure

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The Zoll LifeVest 4000 is a wearable defibrillator used to treat life-threatening abnormal heartbeats (arrhythmias) in adults and children who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator. The LifeVest continuously monitors the patient’s heart and, if a fast, life-threatening heart rhythm is detected, the device delivers a treatment (i.e. a shock) to restore the patient to a normal heart rhythm.

FDA is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102.” Failure to contact Zoll and immediately replace the device after Message Code 102 appears on the device screen may result in serious patient harm or death of the patient because the device may fail to deliver therapy appropriately when needed.

Ideally, the LifeVest monitors the patient’s heart, delivering a “treatment shock” as needed to restore the patient’s heartbeat to a normal rhythm. However, FDA is aware that in certain cases the LifeVest 4000 may not be able to deliver a life-saving treatment shock to a patient due to a fault that prevents the device from charging its high-energy capacitors. During normal operation, this fault prompts the LifeVest to display “Call for service: Device has a problem that may require service. Call Zoll for service, Message Code 102” on the device screen. The “Message Code 102” alert does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.

To date, FDA is aware of one patient death due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed. According to Zoll, as of November 14, 2017, there were a total of 33,670 devices distributed, with 24,975 devices distributed in the U.S. About 0.1% of the total devices distributed have displayed Message Code 102, which should only be remedied by immediate replacement of the device.

The FDA will continue to work with Zoll to monitor LifeVest 4000 devices for any adverse events related to Message Code 102 or a failure to deliver treatment. The FDA will also continue to work with Zoll to identify a permanent solution to the Message Code 102 issue, and will keep the public informed as new information becomes available.

RECOMMENDATION:
For Health care providers –

  • Train patients prescribed use of the Zoll LifeVest 4000 on how to identify the “Call for service, Message Code 102” alert. Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The alert will read “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” and will allow the patient to tap “OK” to return to normal operation.
  • Inform patients to respond to the “Call for service, Message Code 102” alert on the LifeVest 4000 screen by contacting Zoll immediately. Message Code 102 may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed. Zoll will replace the patient’s device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
  • Reinforce initial LifeVest 4000 training, explaining that the device can display messages on the screen and play audio alerts that require the patient to take action. If Message Code 102 does not appear on the device screen, the patient should continue to use the LifeVest 4000 as prescribed, and read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).

For Patients and Caregivers:

  • Contact Zoll immediately if “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” appears on your LifeVest 4000 screen. Message Code 102 may first display as a gong alert, and then subsequently at every power-up until the device is returned to Zoll for servicing. The Message Code 102 alert will also allow you to tap “OK” to return to normal operation.
    > However, the “Call for service, Message Code 102” alert may mean that the LifeVest 4000 has a severe service problem and cannot be used because the device may not appropriately deliver life-saving treatment if needed.
    > Zoll will replace your device within 24 hours if the device displays Message Code 102. Zoll’s Customer Service can be reached 24 hours a day, and 7 days a week at: 1-800-543-3267.
  • Continue to use your LifeVest 4000 as prescribed by your physician and as instructed during your initial training if the “Call for service, Message Code 102” alert is NOT displayed on your device screen. You should continue to read the display for gong alerts and follow the instructions on the screen (refer to Section 5 in the Patient Manual).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

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Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization. To date, there have been no reports of adverse events associated with this issue.

NEXTERONE is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which NEXTERONE is packaged.
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Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter – Anaphylaxis and Other Serious Hypersensitivity Reactions

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Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting—some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration.

Symptoms of anaphylaxis can include wheezing or difficulty breathing, swelling of the face or throat, hives or flushing, itching; abdominal cramping, abdominal pain or vomiting, back pain or chest pain, hypotension or shock.

BACKGROUND: Varubi (rolapitant) injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

RECOMMENDATION: Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.
It is advised that Healthcare professionals consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered Varubi (rolapitant) injectable emulsion.

Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with Varubi (rolapitant) injectable emulsion.

If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs,

  1. administration of Varubi (rolapitant) injectable emulsion should be stopped immediately.
  2. appropriate medical management (including epinephrine and or antihistamines) should be initiated, and
  3. Varubi (rolapitant) injectable emulsion should be permanently discontinued.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  1. Complete and submit the report Online: www.fda.gov/MedWatch/report
  2. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

See the Health Care Provider Letter for important prescribing information to reflect the new safety information.

Datascope recalls certain Intra-Aortic Balloon pumps.

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Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code.

AFFECTED PRODUCT PART NUMBER
CS100i IABP 0998-UC-0446HXX; 0998-UC-0479HXX
CS100 IABP 0998-00-3013-XX; 0998-UC-3013-XX
CS300 IABP 0998-00-3023-XX; 0998-UC-3023-XX

This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP.

Overall Action for User
Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability. Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Please adhere to the following instructions when using affected devices:

  • Pursuant to the USER Instruction WARNINGS, clinicians are instructed not to leave the patient unattended during IABP therapy.
  • An additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. It is important to note the following WARNING in the CS100i, CS100 or CS300 IABP Operating Instructions Manual:

    WARNING: The patient balloon should not remain inactive in the patient (i.e., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.

  • Until the service is performed, we recommend powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.

Datascope has received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve.

There are approximately 12,000 affected units sold globally. The affected IABP units were distributed in the U.S. and worldwide (in over 100 countries). Affected units were distributed between March 23, 2003, and December 11, 2013. Units distributed after December 11, 2013, are not affected by the field correction.

A service representative from Datascope will be replacing the defective solenoid driver boards. Customers having affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service.

For additional information regarding this field correction, please contact the Customer Service Department at 1-888-627-8383 and Press 2 (Monday through Friday from 8:00 a.m. to 6:00 p.m. EDT).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters

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Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter.

This recall does not affect patients who have successfully undergone cardiac procedures using these devices. Abbott has already implemented corrective actions to ensure the products perform as intended.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications leading to death. The FDA has classified this as a Class I recall, where exposure to a device presents a reasonable likelihood of serious adverse health consequences or death. The cumulative frequency of reported events in difficulty of removing the sheath, and inflation and deflation of the balloon, is 0.12 percent worldwide.

Abbott began contacting customers in March who received coronary catheters from the affected lots, and is arranging the return and replacement of all remaining products. The total number of distributed units from identified lots potentially affected is 449,661. Global Health Authorities have been notified of the voluntary recall.

Specific lots of affected product were manufactured between January 1, 2015 to January 2, 2017, and were distributed between January 13, 2015 to March 14, 2017. For more information, please see Abbott’s field safety notice.

For Important Safety Information on NC Trek Catheters see PDF.

ReFlow Medical Issues Recall of Specific Lots of Wingman35 Crossing Catheters

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WASHINGTON, D.C. – On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.

The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury. The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. ReFlow has received 2 complaints of catheter-tip splitting and/or separation. A total of 2327 Wingman catheters are in distribution.

Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

The Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.

ReFlow Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.

FDA and other regulatory agencies around the world have been notified of this action.

Consumers with questions may contact ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Pacific time or by email at info@reflowmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD(TM) System Controllers and DC Adapters as Class I Recall

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Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company’s recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.

Medtronic began notifying clinicians outside of the United States in March 2017 about updated HVAD System Controllers and DC Adapters that were developed following two previously communicated Field Safety Notices that occurred in April 2015 and April 2016. The FDA approved the updated controller on April 7, 2017, and Medtronic began notifying U.S. clinicians about the updated HVAD Controllers and DC Adapters on April 14, 2017.

The updated controller includes enhancements designed to address the potential safety issues identified in the previously communicated notices, including:

  • strengthened power and serial port alignment guides intended to reduce the incidence of wear that could lead to damaged connector pins;
  • functionality designed to monitor internal battery performance and sound an alert when the internal battery is nearing depletion; and
  • redesigned connectors and housing intended to prevent the risk of connectors loosening or becoming more vulnerable to damage from exposure to water and other fluids.

In addition, the updated controller introduces upgraded internal circuitry designed to improve overall device reliability.

In April 2015 and April 2016, Medtronic notified clinicians about potential safety issues with the current HVAD System Controller that could lead to possible injury and death due to worn alignment guides, internal “double disconnect (no power) alarm” battery failure, and loose power and data connectors.

With the introduction of the updated controller, Medtronic has begun to remove current HVAD Controllers (product codes 1400,1401US and 1407US) in select geographies, including the U.S. Medtronic also has begun to remove the related adapters (product code 1435), Instructions for Use, Patient Manuals and Emergency Responder Guides.

As part of these activities, Medtronic has provided the following recommendations to physicians:

  • Before the updated controller will be distributed to hospitals, clinicians must complete required training on the updated controller and updated product labeling, including the Instructions for Use and Patient Manual.
  • Following training and the receipt of the updated controllers in hospital inventory, clinicians are requested to quarantine and replace patients’ primary and backup HVAD Controllers and DC adapters under clinical supervision and at a hospital where patient support equipment is available.
  • While Medtronic recommends that HVAD Controllers be exchanged, clinicians should weigh the benefits of the updated controller against the risks of a controller exchange procedure.
  • When clinicians determine a controller exchange is appropriate, they will notify patients who should promptly schedule a controller exchange as soon as the updated controllers are available.
  • Trained hospital staff must educate patients on using the updated controller.

Patients with questions about this announcement should contact their physicians or ventricular assist device (VAD) coordinator at their hospital center.

Adverse reactions or quality problems experienced with the use of this device may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

For information or to report a problem, please contact the 24-hour Clinical Support line at +1-888-494-6365 or email FSCA@medtronic.com.

Medtronic Announces Voluntary Worldwide Recall of its Stratamr Adjustable Valves and Shunts

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DUBLIN – Medtronic plc today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR™ adjustable valves and shunts. These products are manufactured and marketed by Medtronic’s Neurosurgery business, which is part of the Brain Therapies division of the company’s Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata™ II or Strata™ NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.Medtronic StrataMR adjustable valves and shunts are used in the management of hydrocephalus. They control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure. Medtronic is conducting this voluntary recall due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid.

Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting and lethargy.

  • If any of the affected products have been implanted in patients, physicians should refer to the StrataMR customer recall letter sent February 22, 2017 as well as the valve adjustment instructions in the instructions for use (IFU) for continued patient care.
  • Patients and their caregivers should monitor the patient’s condition and if they find they are experiencing any of the above-mentioned symptoms, they should consult the physician who implanted the StrataMR valve.

If left untreated, under-drainage can potentially lead to coma and death. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.

Medtronic initiated customer communication of the recall by letter and is requesting that customers cease use of all affected product that remains in inventory and return all unused units to Medtronic. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.