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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 and failed reactivations can result in further heart damage or even death. So far, there have been 19 serious incidents and 2 deaths attributed to the equipment.

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