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Health Canada Medical devices

ErgoStar CM 45 and ErgoStar CM 55

Issued November 10, 2025
Issue
The action is being initiated due to a potential issue with the smoothbore hoses of the catheter mounts. Under stress, these hoses could tear, potentially resulting in leakage. If leakage occurs, the ability of ventilators or anesthesia devices to compensate depends on the size of the leak and the ventilation pressure settings. In cases where compensation is not possible, ventilation may be restricted, posing a risk of desaturation or hypoxia for the patient.
Hazard description
Performance
Product
Product name
ErgoStar CM 45 and ErgoStar CM 55
Reference
ID
RA-78457