Health product recall

Uropass Ureteral Access Sheath

Brand(s)
Last updated

Summary

Product
Uropass Ureteral Access Sheath
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Uropass Ureteral Access Sheath

61038BX
61054BX
61146BX
61246BX
61138BX
61324BX
61024BX
61046BX
61254BX
61154BX
61346BX
61354BX
61124BX
61238BX
61224BX
61338BX

Not applicable.

Issue

Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation determined that exposing the Uropass product to ultraviolet ("UV") radiation can cause brittleness of the device dilator tip, which may lead to breakage. Since April 2023, Olympus has received 2 adverse event complaints reporting broken Uropass dilator tips for devices still within their shelf life.

Recall start date: October 4, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Gyrus Acmi, Inc
9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76357

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