FDA: Class I recall of HeartWare Ventricular Assist Device batteries

Editor's Note

The Food and Drug Administration (FDA) on June 29 categorized the recall of HeartWare Ventricular Assist Device (HVAD) batteries by HeartWare Inc (Framingham, Massachusetts) as Class I, the most serious.

The batteries are being recalled because they may lose power prematurely because of faulty cells. If the HVAD system is not connected to an additional power source shortly after the system sounds an alarm indicating low battery level, the pump will stop working and the patient may experience serious adverse consequences, including death.

The recall includes batteries used on HVAD, Serial numbers: BAT000001 to BAT199999, Model number 1650.

Posted 06/29/2016] AUDIENCE: Risk Manager, Nursing ISSUE: HeartWare Inc. is recalling the batteries because they may lose power prematurely due to faulty cells. If the HVAD 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.