Thoratec Corp. (THOR) issued an urgent safety advisory about the use of the pocket controller for its mini heart pump after four patients died and five others were injured.
The notice includes new information and labeling for the HeartMate II LVAS Pocket System Controller prescribed to 2,142 patients since August 2012, Pleasanton, California-based Thoratec said yesterday in a statement. It helps operate the company’s HeartMate II left ventricular assist device, or LVAD, which takes over for a failing heart. Patients and their caregivers encountered problems when changing to a backup controller from their main system, the company said.
