BEUDAMED
    FDA Enforcement Class II Terminated

    US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.

    Recall: Z-0174-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0174-2014
    Event ID
    66597
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St. Jude Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    October 11, 2013
    Classification Date
    November 6, 2013
    Termination Date
    March 10, 2016
    Address
    5050 Nathan Ln N, N/A, Plymouth, MN, 55442-3209, United States

    Description

    US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.

    Reason

    St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).

    Code Info

    Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.

    Distribution

    US distribution: KS, MA, UT,TX, KY, OH.

    Quantity

    59