Medical Device Safety and Recalls: HeartWare Ventricular Assist System - Damaged Alignment Guides / Connection Pins May Cause Pump to Stop

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

Title: Medical Device Safety and Recalls: HeartWare Ventricular Assist System - Damaged Alignment Guides / Connection Pins May Cause Pump to Stop

A recall has been issued for the HeartWare Ventricular Assist System because the alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their VAS. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death.  The company has reported 33 reports of malfunction and one serious injury related to this problem.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm451447.htm

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