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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The latest recall for Medtronic's HeartWare Ventricular Assist Device (HVAD) System was triggered by reports of hardened driveline boot covers, which can make disconnecting the driveline from the controller difficult.
After a flurry of recalls related to its HeartWare Ventricular Assist Device System, Medtronic says a backup controller with modified software is now available in the event of a pump failure for hospitals using the system.
It’s the third high-risk class I action in recent weeks related to the company’s HeartWare Ventricular Assist Device (HVAD) System. It’s also Medtronic’s sixth overall class I since the beginning of March.