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
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