FDA Recalls HVAD Batteries
The U.S. Food and Drug Administration (FDA) issued a safety alert regarding HeartWare Inc.’s Ventricular Assist Device (HVAD) batteries due to premature power depletion. Heartware Inc. reports that the batteries faulty cells, potentially causing the HVAD system to stop working if an additional power source is not connected.
According to the FDA, the recall “includes batteries used on HVAD’s [with] serial numbers: BAT000001 to BAT199999, model number 1650, manufacturing dates: May 19, 2013 to July 1, 2015 and distribution dates: May 21, 2013 to July 31, 2015.”
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support , Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: Electric Power Supplies, Heart-Assist Devices, Safety, United States Food and Drug Administration, Cardiac Surgical Procedures, Angiography
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