BEUDAMED
    FDA Recall Terminated

    Single Chamber Temporary External Pacemaker, Model 53401

    Recall: Z-2317-2018 · Initiated June 6, 2018

    Recall

    Recall Number
    Z-2317-2018
    Event Number
    80267
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    DTE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 6, 2018
    Posted
    June 29, 2018
    Terminated
    August 13, 2021
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Single Chamber Temporary External Pacemaker, Model 53401

    Reason

    A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR).

    Action

    Medtronic began notifying customers, via letter, on about 06/06/2018. Customers were instructed to verify if they possessed affected 53401 EPGs, if they did have affected EPGs to determine if the firmware was updated, to notify all appropriate personnel, to notify customers if the affected devices have been transferred, and to complete and return the Customer Confirmation Certificate. Instructions for determining if the EPG firmware has been updated include: 1) powering the unit on and viewing firmware version; 2) if the firmware version is 01.03.00 or greater, the EPG firmware has been updated with the correction; and 3) if firmware version is 01.02.00, the EPG firmware has not been updated. Medtronic requests that customers arrange to have their EPGs returned for the firmware update.

    Distribution

    Domestic distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Armenia, Austria, Bangladesh, Belgium, China, Dominican Republic, Finland, France, Germany, India, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, Nepal, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Sierra Leone, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    1,108 devices