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 catalog number |
|---|---|---|
| UroPass Ureteral Access Sheath | More than 10 numbers, contact manufacturer. | 61038BX 61054BX 61146BX 61246BX 61138BX 61324BX 61024BX 61046BX 61254BX 61154BX 61346BX 61354BX 61124BX 61238BX 61224BX 61338BX |
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 31st, 2019 are not impacted by this recall.
Recall start date: June 5, 2023
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-73851
Get notified
Receive notifications for new and updated recalls and alerts by category.