FDA Update: Medtronic Issues Class I Recall For HeartWare Ventricular Assist System

Medtronic recently issued a Class I Recall for the HeartWare Ventricular Assist System due to unintended intermittent electrical disconnection between the power source and the controller. Caused by oxidation on the connecting surfaces off the power source connector and the power source socket, interruption in electrical connection may result in a pump stop. Potential pump stops could lead to exacerbation of heart failure symptoms, mild weakness, dizziness, anxiety, nausea, loss of consciousness or death. The 204,017 affected devices in the U.S. were manufactured and distributed between March 2006 and May 2018.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC Advocacy, United States Food and Drug Administration, Dizziness, Vertigo, Heart Failure, Death, Electric Power Supplies, Nausea, Anxiety, Unconsciousness


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