Medtronic will no longer sell and distribute its Heartware Ventricular Assist Device System due to numerous reports of patient harm and death linked to the device, the company said June 3.
The company has also notified physicians to stop implanting the HVAD system, which is used to treat patients with end-stage heart failure.
A growing body of evidence shows patients implanted with the HVAD pump are more likely to die or experience adverse neurological events, such as a stroke, compared to those implanted with similar devices.
Medtronic has received more than 100 complaints involving the delay or failure to restart the heart pump, including 14 reports of patient deaths, according to an FDA health alert. In another 13 cases, clinicians had to remove the device.
Medtronic is creating a support program for about 4,000 patients worldwide and 2,000 in the U.S. implanted with the heart pump.
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