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Terminated

Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Onset Medical, Boston Scientific Corp., Natick, MA 01760

FDA Recall Z-0910-2008 · Posted 2008-04-30

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeEZN
Date Initiated2007-11-30
Date Terminated2008-10-22
Product Quantity177

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.

K061009PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUSOnset Medical Corporation · 2006-05-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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