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