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10 Biggest Medical Device Recalls of 2016—HeartWare

HeartWareDevice: Batteries used for the HeartWare Ventricular Assist Device (HVAD) with serial numbers BAT000001 to BAT 199999, model number 1650.

HeartWare

Device: Batteries used for the HeartWare Ventricular Assist Device (HVAD) with serial numbers BAT000001 to BAT 199999, model number 1650.

Recall reason: According to information on the FDA recall page, "the batteries . . . may lose power prematerly due to faulty cells." If another power source is not connected, "the pump will stop working and the patient may experience serious adverse health consequences, including death."

When recall was initiated: January 7, 2016

Number of U.S. units impacted: 18,631 units

For more information, visit the FDA Recall page.

             

[Image courtesy of PATRISYU/FREEDIGITALPHOTOS.NET]

Take the Medical Innovation Tours during the BIOMEDevice San Jose Conference and Expo, December 7-8.
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