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FDA alerts health care providers to no longer implant heart failure patients with Medtronic s HVAD System 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. Medtronic is stopping the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter requesting physicians to stop new implants of the device. This action comes after the company received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was neces

Abbott heartmateBram zuckermanEmily hendersonRadiological healthDrug administrationOffice of cardiovascular devicesHeartware ventricular assist deviceMedtronic notification letterVentricular assist systemNotification letterCardiovascular devicesWatch adverse event reportingHealth careHeart failureஅப்போட் ஹார்ட்மேட்பிராம் ஸக்மந்