BEUDAMED
    FDA Recall Terminated

    Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop

    Recall: Z-1850-2012 · Initiated May 16, 2012

    Recall

    Recall Number
    Z-1850-2012
    Event Number
    61935
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 16, 2012
    Posted
    June 21, 2012
    Terminated
    February 28, 2013
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop

    Reason

    Difficulty in extending snare loop from the catheter

    Action

    Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Scan and fax to 508-683-5578. For questions regarding this recall call 508-683-8000.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland

    Quantity

    2760 units