Medical Device Safety and Recalls: HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion

HeartWare Inc. has extended a recall to include batteries used in the ventricular assist device 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.

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