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Medtronic Recalls HVAD Pump Implant Kits After 2 Deaths and 19 Serious Injuries
LVAD may have delayed or failed restart after pump is stopped
March 1, 2021 Medtronic is recalling the HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the left ventricular assist device (LVAD) device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations.
If the device has delays or fails to start or restart, this could cause serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death.