Impella Controller

Impella Controller Recall Summary The Impella Controller, a medical device used to support heart function, is being recalled in Canada due to performance concerns. The recall affects all units distributed across Canada. This is classified as a Class I recall, which is the most serious type.

Product
Impella Controller
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-09-18
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/fbe1e109-92aa-48ab-88e2-e3147cb4752a