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 indicates a serious safety concern. The recall affects all Automated Impella® Controllers distributed throughout Canada.

Product

Automated Impella® Controller

Reason

Device performance issue

Classification

Class I

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-04-28

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/af84f219-b95e-4675-b2a6-bffc9c8c1a29