Medtronic HVAD Woes Continue
Medtronic has identified additional HeartWare Ventricular Assist Device pumps that the company says have a higher risk of failure than average for the devices.
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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.
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.
The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.