Medtronic Announces Backup Software For Failed HVAD Pumps
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.
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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.
In a near-repeat of a May recall, the US FDA has labelled Medtronic’s recall of its HeartWare Ventricular Assist Device System class I because of another issue with the system’s batteries.
The company had issued two recalls in the past few months for the device due to recorded deaths and adverse events, but after further analyses has decided to pull it off the market altogether.