Heartmate 3™ System Controller
HeartMate 3™ System Controller Recall Summary The HeartMate 3™ System Controller is being recalled across Canada due to a performance issue. This device is used to operate the HeartMate 3™ heart pump system. The FDA classified this as a Class I recall, indicating a serious problem that could result in patient harm.
- Product
- HeartMate 3™ 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/cb5c7d15-41a5-47eb-b108-5bd90bddb293