FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

HeartWare Broadens Recall for Batteries

July 11, 2016
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HeartWare is extending a recall to include batteries used in HeartWare ventricular assist devices that were manufactured between May 2013 and July 2015. The recall extends to 18,631 units nationwide.

The devices help deliver blood from the heart to the body and are used in patients awaiting a heart transplant. The batteries may lose power prematurely due to faulty cells, which could cause serious adverse events. The FDA has identified the move as a Class I recall, the most serious type of recall. Use of the devices may cause serious injury or death.

The firm initiated an initial recall in January, requesting that healthcare providers quarantine the products and return the devices to the manufacturer.

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