Thoratec Warns Of Potentially Lethal Complications When Patients Switch To New HeartMate II Controller
This article was originally published in The Gray Sheet
Executive Summary
Serious adverse events have been linked to patients struggling to switch their Thoratec HeartMate II left-ventricular assist devices from an older controller system to the newer Pocket Controller system. The company is updating the labeling and training materials for the system and warning doctors and patients to communicate to ensure they understand how to convert to the Pocket Controller.