Medtronic is recalling HeartWare Ventricular Assist Device (HVAD) System batteries because the batteries may experience electrical faults that cause them to unexpectedly fail, according the U.S. FDA. 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.

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.

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. The system operates using power from either AC or DC electricity or batteries.

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

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.