Impella Controller

Impella Controller Recall Summary The Impella Controller device is being recalled across Canada due to a device performance issue. This recall is classified as Class I, which is the most serious classification. The recall affects Impella Controller devices distributed throughout Canada.

Product

Impella Controller

Reason

Device performance issue

Classification

Class I

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-05-13

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b8f1723e-aeeb-4df7-a2e1-e7d1b7b2c235