BEUDAMED
    FDA Enforcement Class II 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 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0187-2014
    Event ID
    66574
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St. Jude Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    October 11, 2013
    Classification Date
    November 8, 2013
    Termination Date
    June 9, 2014
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209, United States

    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.

    Code Info

    Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.

    Distribution

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

    Quantity

    46