BEUDAMED
    FDA Recall Terminated

    7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St Jude Medical Company A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.

    Recall: Z-3257-2011 · Initiated February 10, 2011

    Recall

    Recall Number
    Z-3257-2011
    Event Number
    59683
    FEI Number
    3007562768
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 10, 2011
    Posted
    September 16, 2011
    Terminated
    April 3, 2012
    Address
    St Jude Medical One St Jude Medical Dr, Saint Paul, MN, 55117

    Description

    7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St Jude Medical Company A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.

    Reason

    The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling, St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose, correct version.

    Action

    St. Jude Medical sent an "important Medical Device Safety Information" letter dated February 22, 2011 to all affected customers. The letter includes: affected problem, reconciliation form and corrective action. Customers are asked to remove the incorrect Instructions for Use (IFU) and use the IFU provided in the letter, and to fill out and return the reconciliation form. For questions on this recall please contact the firm at (512) 329-1054 or (651) 756-2869.

    Distribution

    Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.

    Quantity

    179 units total