FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scientific Corp., Natick, MA 01760
- Recall number
- Z-0906-2008
- Recalling firm
- Boston Scientific Corporation
- Product
- Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scientific Corp., Natick, MA 01760
- Status
- Terminated
- Initiated
- 2007-11-30
- Posted
- 2008-04-30
- Terminated
- 2008-10-22
- Reason
- Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 306
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot numbers: W03-1527, W03-1579, W03-1587, W03-1595, W03-1623, W03-1644, W03-1753, W03-1786, W03-1787, W03-1813, W03-1832, W03-1938, W03-2108, W03-2110, W03-2139, W03-2271, W03-2278, W03-2279, W03-2280, W03-2535, W03-2589
- 510(k) numbers
- ["K061009"]
- PMA numbers
- not on file
- Product code
- EZN
- Firm FEI
- 3001451463
- Firm city
- Quincy
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28