A recall of Thoratec’s HeartMate II Left Ventricle Assist System (LVAS) that was first announced in February has been designated Class I, the U.S. Food & Drug Administration’s (FDA) most serious type of recall.
The HeartMate II LVAS is a heart pump which is used as a bridge to transplantation in heart transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIB of IV end-stage left-ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for heart transplantation.
The HeartMate II blood pump delivers blood from the dysfunctional left ventricle of the heart to the rest of the body. It is an axial-flow, rotary ventricular assist system and can generate blood flows up to 10 liters per minute. The device is intended to be used both inside and outside the hospital (e.g., at home), or during transportation of ventricular assist device patients by ground ambulance, airplane or helicopter.
According to a report from The Wall Street Journal, Thoratec received reports of 29 cases in which device wasn’t properly connected. Five of those cases required surgical intervention. In one case the patient died, though it wasn’t clear that the defect caused or contributed to death.
The affected systems were distributed to 226 hospitals and distributors throughout the United States, Europe, Canada and other countries.