FDA Update: Backup Controller For Medtronic HVAD System Available

The U.S. Food and Drug Administration (FDA) announced on Oct. 17 that Medtronic is making a backup controller available to all requesting hospitals for the company's HeartWare Ventricular Assist Device (HVAD) System. The controller has modified software which can be used if the primary controller fails to restart the pump.

Medtronic halted the sale of its HVAD System on June 3, 2021 due to reports of "increased risk of mortality and neurological adverse events in patients using the device" and a malfunction where the device failed to restart.

Access the FDA webpage for more information.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support

Keywords: ACC Advocacy, Heart-Assist Devices, United States Food and Drug Administration, Hospitals, Software

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