FDA Update: Abbott Recalls HeartMate 3 LVAS Implant Kit

The U.S. Food and Drug Administration (FDA) announced on May 15 that Abbott is recalling the HeartMate 3 Left Ventricular Assist System (LVAS) implant kit due to risk of blood leakage or air entering the seal interface between the left ventricular assist device inflow cannula and the apical cuff.

This complication can impact “the integrity of the blood flow and may lead to longer than expected surgery, bleeding (hemorrhage), right heart failure or air embolism,” according to the agency. This is a Class I recall, indicating that use of these devices may cause serious injury or death. For additional details and clinician recommendations, visit the FDA website

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support

Keywords: Heart-Assist Devices, United States Food and Drug Administration, ACC Advocacy

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