FDA issues update on Medtronic’s HeartWare Ventricular Assist Device system
The Food and Drug Administration yesterday provided an update on the HeartWare Ventricular Assist Device system. These updates include new recommendations for patients and providers; information related to FDA’s actions following a June 2022 recall related to battery electrical faults; details on recent recalls conducted by Medtronic including new ways to reduce damage to controller port pins; and information on the system’s pump weld defect.
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