BEUDAMED
    FDA Recall Terminated

    Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.

    Recall: Z-0187-2014 · Initiated October 11, 2013

    Recall

    Recall Number
    Z-0187-2014
    Event Number
    66574
    Firm
    St. Jude Medical
    FEI Number
    3005334138
    Product Code
    OAD
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    October 11, 2013
    Posted
    November 8, 2013
    Terminated
    June 9, 2014
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    Description

    Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.

    Reason

    St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.

    Action

    Consignees were sent a St. Jude Medical "Urgent Medical Device Notice" dated 11 October 2013. The letter was addressed to Cath lab manger / Risk Manger. The letter described the problem and the product involved in the recall. The letter stated that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.

    Distribution

    Nationwide Distribution including the states of KY, OH, TX, MA, and NC.

    Quantity

    46