Medtronic ends sales of heart-failure device after adverse events
June 4, 2021
Medtronic PLC is discontinuing all implants of one of its most complex and costly heart-failure devices, the HeartWare Ventricular Assist Device, five years after the Minnesota device maker acquired the HVAD's maker in a $1.1 billion deal.
Medtronic and the U.S. Food and Drug Administration announced Thursday that the device should no longer be implanted following reports that the system - which circulates oxygenated blood when the patient's heart is failing - is associated with more deaths, strokes and device problems than a competing system made by Abbott Laboratories.
Medtronic has reported more than 100 patient complaints involving a delay or failure in restarting the devices' implantable blood pump, "which led to a total of 14 deaths and 13 pump removals," the FDA says. About 2,000 HVADs are currently implanted in the U.S., out of 4,000 implants worldwide.