Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Lot numbers: W03-1606, W03-1649 W03-1700, W03-1702, W03-1924, W03-2077, W03-2143, W03-2277, W03-2283
Products Sold
Lot numbers: W03-1606, W03-1649 W03-1700, W03-1702, W03-1924, W03-2077, W03-2143, W03-2277, W03-2283
Boston Scientific Corporation is recalling Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 25510 due to Sheath Removal Difficulty: Users experience difficulty in removing the sheath.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Recommended Action
Per FDA guidance
Consignees were sent an Urgent Medical Device Recall letter on November 29, 2007. The letter instructed users to check their inventory, remove any affected product and place them in quarantine. It also included instructions for returning the product. Users were asked to return a Reply Verification Tracking Form. Follow-up communication will be made to users who do not return the tracking form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026