Back to RecallTracker
Health Canada Medical devices

Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump

Issued February 17, 2023
Issue
There is a potential for the following 4 issues to occur: 1. unexpected shutdown due to failure of the connection with the coiled cable cord (serial numbers specific); 2. unexpected shutdown due to loss of communication between the executive processor PCBA and the video generator PCBA resulting in code 111/code 112; 3. helium leak due to the high pressure helium regulator; 4. helium leak due to a worn, torn or damaged o-ring on the quick disconnect fitting. Recall start date: February 10, 2023
Hazard description
Performance
Product
Product name
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Reference
ID
RA-72688