Heartmate Ii® Lvas - System Controller
HeartMate II® LVAS System Controller Recall The HeartMate II® LVAS System Controller, a device used to operate left ventricular assist systems (mechanical heart pumps), has been recalled across Canada due to a performance issue. This recall is classified as Class I, meaning the device could potentially cause serious harm or death. The recall affects patients in Canada who use this system controller.
- Product
- HeartMate II® LVAS - System Controller
- Reason
- Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2025-10-17
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/46100e17-7f93-4d79-94a8-2aa3630c65dc