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Health Canada Medical devices

Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump

Issued January 4, 2023
Issue
Datascope/Getinge has received complaints reporting unexpected shutdown of the Cardiosave IABP while providing therapy in very rare instances. An internal investigation of the complaints determined an unexpected shutdown may be due to blood entering into the Cardiosave IABP when therapy is provided with a perforated intra-aortic balloon catheter. Recall start date: December 21, 2022
Hazard description
Performance
Product
Product name
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Reference
ID
RA-72511