Automated Impella Controller (aic)

Automated Impella Controller (AIC) Recall Summary The Automated Impella Controller (AIC) is being recalled in Canada due to a device performance issue. This is a Class II recall, meaning the device could cause serious health problems but is not expected to cause death. The recall affects devices distributed across Canada.

Product

Automated Impella Controller (AIC)

Reason

Device performance issue

Classification

Class II

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-08-27

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b567d3ba-557b-4a69-ad58-dab38957ea58