BEUDAMED
    FDA Recall Terminated

    Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.

    Recall: Z-1876-2009 · Initiated July 6, 2009

    Recall

    Recall Number
    Z-1876-2009
    Event Number
    52659
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 6, 2009
    Posted
    September 9, 2009
    Terminated
    October 8, 2010
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.

    Reason

    The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.

    Action

    Boston Scientific notified consignees by letter dated 7/6/09 and instructed to cease using and to return the products, and to complete and return a reply form.

    Distribution

    Nationwide.

    Quantity

    2,774