BEUDAMED
    FDA Recall Terminated

    Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345. Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters.

    Recall: Z-2955-2011 · Initiated June 1, 2011

    Recall

    Recall Number
    Z-2955-2011
    Event Number
    59392
    Firm
    St. Jude Medical
    FEI Number
    2182269
    Product Code
    IKD
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 1, 2011
    Posted
    August 5, 2011
    Terminated
    August 16, 2012
    Address
    14901 DeVeau Place, Minnetonka, MN, 55345

    Description

    Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345. Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters.

    Reason

    St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding Quadripolar catheter but cannot be incorrectly connected to a Hexapolar catheter.

    Action

    St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE FIELD ADVISORY NOTICE" letter dated June 8, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate the affected product and to complete and return an attached SJM AFD Reconciliation Form. The form will be used to replace product and as documentation that the customers received the notice. Fax the completed form to 877-497-031. Contact the Director of Product Marketing at 512-329-1054 for questions regarding this notice.

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of FL, NC, NY, and OR.

    Quantity

    32