HeartWare International has recalled its ventricular assist system because the power-supply connector ports can wear down, stopping the pump and leading to patient death, according to FDA.
The Framingham, MA company has reported one serious injury and 33 complaints of malfunction. Heart-transplant candidates with end-stage, left-ventricular heart failure use the system to help deliver blood from the heart to the rest of the body, FDA said in a statementabout recall.
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