BEUDAMED
    FDA Recall Terminated

    Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.

    Recall: Z-0946-2009 · Initiated December 9, 2008

    Recall

    Recall Number
    Z-0946-2009
    Event Number
    50521
    Firm
    St. Jude Medical Inc
    FEI Number
    2938836
    Product Code
    OCL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 9, 2008
    Posted
    January 30, 2009
    Terminated
    December 28, 2010
    Address
    240 Santa Ana Ct, Sunnyvale, CA, 94085-4512

    Description

    Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.

    Reason

    Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.

    Action

    The firm issued notification by "Urgent Product Recall" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423.

    Distribution

    Worldwide - NY, IN, NC, UT, OR, CA, IL, MI, TX, TN, and FL and country of Belgium.

    Quantity

    158 units distributed.