Automated Impella Controller
Automated Impella Controller Recall The Automated Impella Controller, a medical device used to support heart function, is being recalled across Canada due to a device performance issue. This is a Class I recall, which means the device could cause serious harm or death. The recall affects all Automated Impella Controllers distributed in Canada.
- Product
- Automated Impella Controller
- Reason
- Device performance issue
- Classification
- Class I
- Category
- medical device recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2026-02-25
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/721598cc-7e21-4922-be04-b644256bbca8