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Health Canada Medical devices

Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump

Issued December 13, 2021
Issue
The exterior of the cardiosave hybrid and rescue IABP may be susceptible to fluid ingress at specific locations on the device. IABPs contain various electronic circuit boards. Liquid spills, such as saline, can create bridges of resistance between the circuit components; causing the circuit to not function as intended. This can impact initiation or continuation of counterpulsation therapy. Recall start date: Nov 22, 2021
Hazard description
Manufacturing defect
Product
Product name
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Reference
ID
RA-63710