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 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
2025-07-09
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/15630d66-cb4e-4b65-a96f-f81158cd54e8