FDA Update: Agency Announces Recall of Medtronic HVAD Pump Implant Kit For Pump Weld Defect
The U.S. Food and Drug Administration (FDA) on June 8 announced a recall by Medtronic of the company’s HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit. The FDA has indicated that this is a Class I recall, where continued use of the device may cause “serious injury or death.”
Medtronic is recalling the HVAD Pump Implant Kit because of a pump weld defect, which has led to cases where moisture is able to enter the pump and cause the internal magnets in the device to corrode and demagnetize. According to the FDA, “Patients with affected devices may present with signs and symptoms that resemble pump thrombosis.”
For more information on the HVAD Pump Implant Kit recall, visit the FDA website.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Heart Transplant, Mechanical Circulatory Support
Keywords: Heart Transplantation, Thrombosis, United States Food and Drug Administration, Magnets, Heart-Assist Devices, ACC Advocacy
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