Thoratec Corp. issued an urgent safety advisory about the HeartMate II LVAD Pocket System Controller for its mini heart pump after four patients died and five others were injured.
The notice includes new information and labeling for the controller, which has been prescribed to 2,142 patients since August 2012. It helps operate the company’s HeartMate II left ventricular assist device (LVAD), which takes over for a failing heart.
“Consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated patient handbook information,” the company said.
Patients and their caregivers encountered problems when changing to a backup controller from the main system, according to Thoratec. Two of the deaths occurred when patients tried to change the controller themselves, and the five injured lost consciousness or suffered from decreased blood flow.
Thoratec said it didn’t find any flaws with the controllers and it didn’t request their return. Patients who received the pocket controller as a replacement for an older model — which works differently — are at a higher risk for encountering problems, the company said, because they may not have received adequate training.