FDA Update: Agency Announces Recall of Medtronic HeartWare HVAD System Batteries

The U.S. Food and Drug Administration (FDA) announced on June 23 the recall of Medtronic’s HeartWare Ventricular Assist Device (HVAD) System Batteries due to battery failure. This is a Class I recall, where continued use of the device may cause “serious injury or death.”

Medtronic’s HeartWare HVAD System is used to assist the heart in pumping blood to the rest of the body. The company is recalling a single lot of HeartWare HVAD System batteries because of “welding defects that allow separation of the two cell battery packs used to power the system.” The defect may cause the battery to fail suddenly.

For more information, access the FDA’s announcement on the recall.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant, Mechanical Circulatory Support

Keywords: Heart Failure, Heart Transplantation, Welding, United States Food and Drug Administration, Heart-Assist Devices

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