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Recall Of Medtronic’s HeartWare Pump Kits Labeled Class I By FDA; Deaths, Injuries Reported

 
• By Shawn M. Schmitt

The recall of the kit, which is part of the HeartWare HVAD System, was affixed with the US agency’s highest risk classification on 1 March.

Sign of Medtronic at Canada Headquarters in Brampton, Ontario, Canada.

The US Food and Drug Administration has classified a recall of Medtronic PLC’s HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as high-risk class I. Two deaths and 19 serious injuries have been reported, the agency said on 1 March.

The FDA says “the device may fail to initially start, restart or have a delay in restarting after the pump was stopped. …If the device has delays or fails to...

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