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Health Canada Medical devices

Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump

Issued March 16, 2023
Issue
While conducting safety disk testing, expired tubing was used on the test fixture equipment between April 01, 2022 and July 31, 2022. when using the obsoleted, and expired catheter extender tube, 0004-00-0033-01 during the static inflate/deflate test method can potentially lead to non-conforming bolted safety disks to pass the displacement test. This potential failure may lead to reduced IAB inflation during therapy. Recall start date: March 6, 2023
Hazard description
Performance
Product
Product name
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Reference
ID
RA-73334