BEUDAMED
    FDA Recall Open, Classified

    MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)

    Recall: Z-1358-2022 · Initiated May 23, 2022

    Recall

    Recall Number
    Z-1358-2022
    Event Number
    90370
    Firm
    Medtronic MiniMed
    FEI Number
    3003166194
    Product Code
    OZP
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 23, 2022
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)

    Reason

    Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.

    Action

    On 05/24/2022, Medtronic began communicating an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers informing them of the battery cap issue where if the metal contact becomes loose or falls off from the battery cap, it can result in an incomplete battery connection, leading to no power source to the insulin pump. Actions Required by customers: Before beginning: Do not remove the battery cap unless you have a new battery available. If you have a spare undamaged battery cap, ensure it is available nearby. During routine battery replacement, check the metal contact on your pump battery cap to see if it is loose, damaged, or missing. You can view animated instructions on how to inspect the battery cap contact through our website at www.medtronicdiabetes.com/battery-cap-guide. " If the battery cap contact is damaged, immediately replace it with a spare cap that you received with original pump shipment, and discard the damaged cap. If no spare cap, stop using pump and revert to a back-up plan per healthcare provider s recommendations. Then, request a spare battery cap online at www.medtronicdiabetes.com/battery-cap-form, or contact Medtronic 24-Hour Technical Support at 877-496-7933. " If unsure that the battery cap contact are damaged, replace it with a spare cap or request a spare battery cap online at www.medtronicdiabetes.com/battery-cap-form, or contact Medtronic 24-Hour Technical Support at 877-496-7933. " If the battery cap contact is not damaged, continue to use your pump and monitor for cap damage during battery replacement, and complete and return the attached confirmation form by mail. Medtronic will send you a spare cap in the coming months. " Always pay close attention to the pump and pump battery status after inserting the new battery. For questions, contact Medtronic 24-Hour Technical Support at 877-496-7933.

    Distribution

    U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY O.U.S.: Not provided

    Quantity

    123,585 pumps