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Health Canada Medical devices

UroPass Ureteral Access Sheath

Issued June 19, 2023
Issue
Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation showed that reported breakages were associated with devices aged more than three years. Devices manufactured after December 31 st , 2019 are not impacted by this recall. Recall start date: June 5, 2023
Hazard description
Performance
Product
Product name
UroPass Ureteral Access Sheath
Reference
ID
RA-73851