FDA Recalls HVAD Pumps Due to Contamination and Electrical Issues

HeartWare Inc. issued a class I recall for its ventricular assist device (HVADs) pumps due to contamination leading to electrical issues. A design flaw in the driveline tube that connects the pump to the external controller and power source may result in fluid and other materials entering the pump. Contamination resulting in electrical failures or pump stops may lead to serious health complications or death. Devices with serial numbers under HW25838, product codes 1103 and 1104, and manufactured between March 17, 2006 and June 27, 2016 are subject to the recall. 105 HVADs have been recalled in the U.S.

Read the FDA announcement.

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

Keywords: Clinical Coding, Death, Electric Power Supplies, Heart-Assist Devices

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