—#67195

Product

Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Onset Medical, Boston Scientific Corp., Natick, MA 01760

FDA product code: EZN — Dilator, Catheter, Ureteral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K061009
Affected lot / code info: Lot Number: W03-2341, W03-2357, W03-2395, W03-2578

Why it was recalled

Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 500 Commander Shea Blvd, Quincy, Massachusetts 02171-1518

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2007-11-30
Posted by FDA: 2008-04-30
Terminated: 2008-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67195. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.