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Class I Recall: Medtronic HVAD Pump Implants Sean Marsala © REUTERS/Jason Reed The corporate logo of the U.S. Food and Drug Administration (FDA), which handles recalls and safety standards for a variety of products including food, medicine, and medical devices. A high-priority new recall has been issued for Medtronic HVAD Pump Implant Kits. These kits are used in patients suffering from severe heart disease, especially those in need of a transplant but who have not yet found a donor. When this issue occurs, the pumps will not react as intended to restart the heart. Delays ...

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 r...