BEUDAMED
    FDA Recall Terminated

    Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.

    Recall: Z-0905-2014 · Initiated November 12, 2013

    Recall

    Recall Number
    Z-0905-2014
    Event Number
    66835
    Firm
    Medtronic Advanced Energy, LLC
    FEI Number
    1000517638
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 12, 2013
    Posted
    January 31, 2014
    Terminated
    April 3, 2014
    Address
    180 International Dr, Portsmouth, NH, 03801-6837

    Description

    Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.

    Reason

    The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use.

    Action

    Medtronic sent an Urgent Product Removal Notification on November 12, 2013, via Next Day FEDEX. The communication advises users to immediately stop using the affected AQM3 electrosurgical generators and quarantine them until they can be returned to Medtronic Advanced Energy. Medtronic field personnel will collect them in order to remove them from service and return them to Medtronic Advanced Energy. Customers with questions were instructed to contact Customer Service at 866-777-9400. For questions regarding this recall call 866-777-9400.

    Distribution

    Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.

    Quantity

    242 devices