The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public of a
Class I recall of HeartWare Ventricular Assist System (VAS). According to the FDA, the alignment guides
in the power supply connector ports may wear down over time which 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.
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