BEUDAMED
    FDA Recall 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 · Initiated January 14, 2013

    Recall

    Recall Number
    Z-0912-2013
    Event Number
    64404
    Firm
    Atricure Inc
    FEI Number
    3011706110
    Product Code
    OCL
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 14, 2013
    Posted
    March 6, 2013
    Terminated
    June 11, 2013
    Address
    6217 Centre Park Drive West, Chester, OH, 45069

    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.

    Action

    AtriCure sent a Urgent Medical Device Recall/Correction letter dated January 14, 2013, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. If the MAX1 is used as intended there is no risk to the patient as a result of this issue. The correct instructions for Use for the MAX1 Pen is included with this notification. AtriCure will replace any affected product if requested by the facility. Please review and fill out the attached " Acknowledgement Form" and either fax to AtriCure at (513) 644-4753. If you need to contact customer service, their number is 1-866-349-2342.

    Distribution

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

    Quantity

    5 devices