BEUDAMED
    FDA Recall Terminated

    CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503658X

    Recall: Z-1495-06 · Initiated July 21, 2006

    Recall

    Recall Number
    Z-1495-06
    Event Number
    35940
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    DXQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2006
    Posted
    September 9, 2006
    Terminated
    November 19, 2008
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503658X

    Reason

    Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.

    Action

    A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06.

    Distribution

    World wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands

    Quantity

    740