August 5, 2014 — HeartWare International Inc. has initiated a recall to address more safety problems with the HeartWare Ventricular Assist Device (HVAD), a heart pump for patients with end-stage heart failure.
HeartWare issued a statement on May 1 after observing an increase in complaints related to earlier-than-expected battery depletion.
“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.”
If the battery behaves unusually or does not provide 2 hours of support, patients and caregivers are instructed to contact the VAD Coordinator at their hospital. They may need to replace the battery.
HeartWare says no deaths have been directly caused by faulty batteries. However, between January 1, 2011and March 31, 2014, three deaths were linked to power source management issues. Two occurred after both sources of power were simultaneously disconnected and a third death occurred because of an old battery.
A fourth death was linked to a disconnected driveline, which led HeartWare to issue a voluntary Class I recall in April 2014. Two months later, the FDA issued a warning letter after inspectors found problems at a manufacturing facility in Miami Lakes, Florida.
In February 2013, the FDA reported the death of a woman who died after she tried to change the batteries in her HVAD. The power dropped and blood-flow fell, setting off an alarm.
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