BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0911-2008 · Initiated November 30, 2007

    Recall

    Recall Number
    Z-0911-2008
    Event Number
    46330
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    EZN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 30, 2007
    Posted
    April 30, 2008
    Terminated
    October 22, 2008
    Address
    500 Commander Shea Blvd, Quincy, MA, 02171-1518

    Description

    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

    Reason

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

    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.

    Distribution

    Nationwide Distribution

    Quantity

    165