Sunday, April 23, 2017
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HeartWare(HVAD) Battery Recall

Heartware Ventricular Assist Device Batteries Recalled.

FDA issues class I recall of Heartware Ventricular Assist Device (HVAD) Batteries.

HeartWare Inc. has issued a nationwide recall of batteries for their HeartWare ventricular assist device (HVAD) because they may lose power prematurely. The HVAD is a machine used to assist the heart in delivering blood in patients at risk of heart failure. It consists of a pump implanted near the heart and a controller that regulates the speed and function of the pump.

The HVAD sounds an alarm when the battery level is low. If the system is not connected to an additional power source after the alarm sounds, the pump may stop working, putting the patient at risk for serious health consequences, including death.

The battery recall includes serial numbers: BAT000001 to BAT199999, model number 1650, manufacturing dates: May 19, 2013 to July 1, 2015 and distribution dates: May 21, 2013 to July 31, 2015. A total of 18,631 units were recalled nationwide, including Washington D.C.

HeartWare Inc. has asked patients who have batteries included in this recall to contact the company and return the batteries. Visit the FDA website for full recall information.

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