Cardiosave System - Hybrid & Rescue Intra-aortic Balloon Pump

Cardiosave System Hybrid and Rescue Intra-Aortic Balloon Pumps are being recalled across Canada due to a manufacturing defect. These devices are used to support heart function in certain patients. This is classified as a Class I recall, indicating the most serious type of safety issue.

Product

Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump

Reason

Manufacturing defect

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-12-13

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/2899c1ce-710a-462f-a130-aa2c1fef722c