BEUDAMED
    FDA Enforcement Class II 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 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0905-2014
    Event ID
    66835
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Advanced Energy, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    November 12, 2013
    Classification Date
    January 31, 2014
    Termination Date
    April 3, 2014
    Address
    180 International Dr, Portsmouth, NH, 03801-6837, United States

    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.

    Code Info

    lowest serial number is GN001141; the highest is GN001704 (non-consecutive)

    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