Abbott-Thoratec HeartMate Controller Recall Class 1

FDA says the Abbott-Thoratec 3/29 recall of its HeartMate II LVAS pocket system controller is Class 1. The device was recalled due to risk of patient injury and/or death during backup controller exchange, an agency notice says. The controller is a power supply that connects to an implanted HeartMate II LVAS pump through a lead under the skin. It helps power the LVAS system.

The notice says Abbott-Thoratec has received 70 reports of incidents in which the controller malfunctioned after an exchange, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital. FDA says such changes should be done at the hospital because they can present a significant challenge to patients who are elderly and/or untrained.

The companies are providing all users with new software and hardware updates to assist patients in successfully changing their pocket controllers in emergency situations, FDA says.