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
FDA Recall Z-0906-2008 · Posted 2008-04-30
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeEZN
Date Initiated2007-11-30
Date Terminated2008-10-22
Product Quantity306
Reason for Recall
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.