Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries
Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System controllers.
- Product
- HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
- Category
- Medical Device
- Distribution
- Distributed nationwide