Thoratec is initiating a worldwide recall of their HeartMate II Left Ventricular Assist System.
Thoratec Corp. has initiated a worldwide recall of its left ventricular assist system (LVAS) back-up system controller due to insufficient labelling and training for patients who updated from an older version of the controller, the US Food and Drug Administration (FDA) announced today.
The recalled Pocket System Controller connects an implanted HeartMate II LVAS pump through a driveline under the skin. The EPC controller helps power the LVAS system, which circulates blood throughout the body when the heart is too weak to do so sufficiently on its own.
Thoratec has recalled the system after receiving 5 reports of serious injury and 4 reports of death associated with updating to the back-up system controller. The patients who were affected by the switch did not receive adequate training on how to connect the new controller, which differs in design from the older model.
The controller can be operated by batteries or a connection to a main power supply, but without a proper connection, the device cannot function. Instructions for switching from one controller to a back-up system in case of alarm or malfunction are currently included with the system.