Medtronic Issues Another Recall For The HeartWare VAD System
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.
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ECRI says gaps in communication about recalls of medical devices used at homes pose a significant risk to patients. The nonprofit safety organization’s list of the top ten technology hazards for 2023 put lack of communication at the top.
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.
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.