June 29, 2016: HeartWare Recalls Ventricular Assist Device Batteries – Premature Power Depletion

HeartWare Recalls Ventricular Assist Device Batteries

HeartWare Recall – The Issue

On June 29, 2016, HeartWare Inc. recalled the batteries for their Heartware Ventricular Assist Device because the batteries contain faulty cells that may cause the device to lose power prematurely.

The U.S Food and Drug Administration (FDA) provided the following battery recall 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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