Medical Device Safety and Recalls: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues

HeartWare Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD's pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.

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