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HeartWare HVAD Recall Issued for Faulty Battery

HeartWare HVAD Recall Issued for Faulty Battery

August 5, 2014 — HeartWare Inc. has announced a voluntary recall of the HeartWare Ventricular Assist Device (HVAD) to address safety problems with batteries that can deplete earlier than expected.

The recall was initiated after HeartWare noticed an increase in the number of complaints related to battery depletion.

According to a statement from the company:

“Similar to the battery in a mobile cell phone, HeartWare batteries will begin to lose charge over time. If a fully-charged battery lasts less than two hours or if the controller switches back-and-forth between batteries, patients are asked to take the affected battery out of service and replace it with a new one.”

The faulty batteries have not been directly linked to any deaths. However, between January 1, 2011 and March 31, 2014, power source management issues were blamed on three deaths. Two of those deaths occurred after both power sources were simultaneously disconnected. An old battery was blamed on the third death.

HeartWare also said a fourth death was originally blamed on power source management problems, but was later determined to be linked to an accidental disconnection of the driveline. HeartWare recalled the HVAD for the driveline problem in April 2014. In June, the FDA issued a warning letter.

One of the first deaths linked to these problems was reported to the FDA in February 2013. A woman who had been implanted with the HVAD for three years tried to change the battery, but it suddenly shut off the power and blood-flow.

Do I have a HeartWare HVAD Lawsuit?

The Schmidt Firm, PLLC is currently accepting HeartWare HVAD induced injury cases in all 50 states. If you or somebody you know has been injured by defective batteries, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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