The U.S. Food and Drug Administration on June 3 alerted health care providers to stop implanting Medtronic's Heartware Ventricular Assist Device (HVAD) System in end-stage heart failure patients. This action follows instructions provided in a Medtronic Urgent Medical Device Communication Notification Letter, and takes into account data demonstrating higher rates of neurological adverse events and mortality associated with the system compared to other commercially available devices, as well as complaints that the internal pump may delay or fail to restart.

Over 100 complaints associated with delay or failure to restart of the HVAD pump have been reported, including reports of 14 patient deaths and 13 cases requiring explant. Medtronic, who has stated that there are approximately 2,000 patients in the U.S. implanted with the device and 4,000 worldwide, has stopped the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter requesting physicians stop new implants of the device.

Read the full FDA alert and more details from the Medtronic Notification Letter here..

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

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

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