FDA alerts health care providers to no longer implant heart failure patients with Medtronic’s HVAD System

By | June 3, 2021
The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available devices, as well as complaints that the internal pump may delay or fail to restart.