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June 29, 2016: HeartWare Faulty Battery in Ventricular Assist Device Recalls

HeartWare Faulty Battery

ISSUE:

HeartWare Inc. has issued a recall of the batteries to their Ventricular Assist Device because these batteries contain faulty cells that may cause the device to lose power prematurely.

The FDA provided the following information in a June 29, 2016 News Release.

If the battery of the HeartWare Ventricular Assist Device system is not connected to an additional power source shortly after the system sounds an alarm indicating a low battery level, the pump will stop working and the patient may experience serious adverse health consequences, including death

BACKGROUND:

The HeartWare Ventricular Assist Device is used to deliver blood from the heart to the rest of the body in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant.

The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump.
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Recalled Product:

Batteries used on HeartWare Ventricular Assist Device (HVAD)

  • Serial numbers: BAT000001 to BAT199999
  • Model number: 1650
  • Manufacturing dates: May 19, 2013 to July 1, 2015
  • Distribution dates: May 21, 2013 to July 31, 2015
  • Devices recalled in the U.S.: 18,631 units nationwide, including Washington D.C.

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