BEUDAMED
    FDA Recall Terminated

    Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

    Recall: Z-0080-2013 · Initiated September 17, 2012

    Recall

    Recall Number
    Z-0080-2013
    Event Number
    63336
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    JOS
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 17, 2012
    Posted
    October 18, 2012
    Terminated
    July 17, 2013
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

    Reason

    Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.

    Action

    Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.

    Distribution

    Distributed in Brazil, Portugal and Hong Kong.

    Quantity

    19,716 units distributed total