Medtronic stops distribution of HeartWare HVAD system in United States.
Medtronic is stopping the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter External Link Disclaimer 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 necessary. According to Medtronic, there are approximately 2,000 patients in the U.S. implanted with the device and 4,000 worldwide.
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