Automated Impella® Controller
Automated Impella® Controller Recall The Automated Impella® Controller, a device used to support heart function, is being recalled in Canada due to performance issues. This recall affects all units distributed across Canada. The FDA has classified this as a Class I recall, which indicates a serious issue with the device's operation.
- Product
- Automated Impella® Controller
- Reason
- Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2025-10-23
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/87a3b887-c343-44d4-a484-76a773eb0780