BEUDAMED
    FDA Enforcement Class II Terminated

    Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

    Recall: Z-0912-2013 · Reported March 13, 2013

    Enforcement

    Recall Number
    Z-0912-2013
    Event ID
    64404
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atricure Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 13, 2013
    Initiation Date
    January 14, 2013
    Classification Date
    March 6, 2013
    Termination Date
    June 11, 2013
    Address
    6217 Centre Park Drive, N/A, West Chester, OH, 45069, United States

    Description

    Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

    Reason

    Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.

    Code Info

    Model Number(s): MAX1 A000163, Lot Number 41865

    Distribution

    Nationwide Distribution including the states of MD, PA and TX.

    Quantity

    5 devices