Z-0911-2008

Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106...

Name: Z-0911-2008 Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106...
Creator: Boston Scientific Corporation
Published: 2007-11-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-11-30 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston... on 2007-11-30. The reason FDA records is "Sheath Removal Difficulty: Users experience difficulty in removing the sheath". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0911-2008
Status: Terminated
Initiated: 2007-11-30
Posted: 2008-04-30
Terminated: 2008-10-22
Recalling firm: Boston Scientific Corporation
Product: Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston Scientific Corp., Natick, MA 01760
Product code: EZN Dilator, Catheter, Ureteral
Reason for recall: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Root cause tag: design
FDA 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 in commerce: 165
Distribution: Nationwide Distribution
Product codes and lots: Lot numbers: W03-2337, W03-2359, W03-2392, W03-2553, W03-2554, W03-2590

Product code EZN

K061009Class IIPathway Balloon Expandable Ureteral Access Sheath, Model BeusOnset Medical Corporation / cleared 2006-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)