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
Get notified
Receive emails about new and updated recall and safety alerts.