Abiomed Introducer Kits With Impella Heart Pumps

Abiomed Introducer Kits used with Impella Heart Pumps are being recalled in Canada due to a device performance issue. The kits are used to insert the Impella heart pump during medical procedures. This is a Class I recall, which indicates a serious potential for adverse health effects.

Product

Abiomed Introducer Kits with Impella Heart Pumps

Reason

Device performance issue

Classification

Class I

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-06-29

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e33a9314-fcc6-448d-a05a-f43d3e422191