FDA MedWatch - HeartWare HVAD System Batteries by Medtronic

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

AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology

ISSUE: Medtronic is recalling HeartWare HVAD System batteries because the batteries may experience electrical faults that cause them to unexpectedly fail. When this occurs batteries with an electrical fault may be unable to power the controller, unable to accept charge from the battery charger, or appear to remain charged when in use.

If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death.

Medtronic reports 1,159 complaints, six injuries, and one death related to this issue.

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

BACKGROUND: The HeartWare Ventricular Assist Device (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. The system operates using power from either AC or DC electricity or batteries.

RECOMMENDATIONS: On June 28, 2022, Medtronic issued an Urgent Medical Device Correction letter to affected customers about this issue as well as a previous battery recall. This letter also asked customers to take the following actions to help address the battery electrical fault:

• Keep two sources of power connected to their controller and have fully charged spare batteries available at all times.
• Acknowledge and report alarms.
• Follow the Instructions for Use (IFU) for proper power source management.
• Be vigilant if the battery indicator lights do not decrease over time while the battery is in use.
• Pay attention to the battery indicator lights.
  • Do not use a battery if the indicator lights do not light up.

The Letter provided additional instructions for customers including:

• Complete a customer confirmation form and return it to the company.
• Share the letter with all those who need to be aware within the organization and with any organization where patients 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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