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Health Canada Medical devices

EZDilate Balloon Dilators

Issued December 4, 2023
Issue
Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving the devices, as well as reports of bursting and leaking. Olympus has received reported adverse events involving foreign body in patient and prolonged procedure. Recall Start Date: November 21, 2023
Hazard description
Performance
Product
Product name
EZDilate Balloon Dilators
Reference
ID
RA-74670