FDA MedWatch - HeartWare HVAD System Batteries by Medtronic

U.S. Food and Drug Administration sent this bulletin at 06/24/2022 08:12 AM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: HeartWare HVAD System Batteries by Medtronic: Class I Recall - Due to Battery Failure

AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology

ISSUE: Medtronic is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries due to welding defects that allow separation of the two cell battery packs used to power the system. The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging. As a result, the battery may fail suddenly.

If this malfunction occurs, it will trigger a Power Disconnect alarm on the controller screen and in the Alarm Log tab of the HVAD Monitor while the affected battery is still connected to the controller. These alarms may temporarily resolve, but the battery will continue to fail.

The use of these batteries may lead to device malfunction, death, or serious injury.

Medtronic reports one death associated with this recall, and two complaints in the affected lot.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The HeartWare HVAD System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned.

RECOMMENDATIONS: On May 5, 2022, Medtronic sent an Urgent Medical Device Correction letter to all affected customers.

Immediately identify and quarantine all affected batteries.
Immediately notify patients with affected batteries that Medtronic is conducting this retrieval and have them remove these batteries from service. Medtronic has provided a patient template that may be used to communicate directly with patients.
Contact a Medtronic Field Representative to assist you in the return of the affected product.
Complete the Customer Confirmation Form and follow the instructions to initiate an exchange.
Share this notice to all those who need to be aware within your organization or to any organization where the affected batteries have been transferred.

Health 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.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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