Introducer Kits In Impella Pump Set And Axillary Insertion Kit

Introducer kits included in Impella Pump Sets and Axillary Insertion Kits are being recalled across Canada due to labelling and packaging issues. This is a Class I recall, which indicates a serious potential health risk. The recall affects all Impella Pump Sets and Axillary Insertion Kits distributed in Canada that contain these introducer kits.

Product

Introducer kits in Impella Pump Set and Axillary Insertion Kit

Reason

Labelling and packaging

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2023-12-21

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/c738ed85-7ea6-48f6-9eb4-27774628c1c3