Impella® Controller
Impella® Controller Recall Summary The Impella® Controller device is being recalled in Canada due to a performance issue. This recall affects all Impella® Controller units that were distributed across Canada. The recall is classified as Class I, which is the most serious type.
- Product
- Impella® Controller
- Reason
- Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2025-08-29
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4d140059-d58e-43e0-bfdc-fab209fd926b