BEUDAMED
    FDA Recall Open, Classified

    MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

    Recall: Z-1635-2026 · Initiated January 30, 2026

    Recall

    Recall Number
    Z-1635-2026
    Event Number
    98444
    Firm
    Medtronic MiniMed, Inc.
    FEI Number
    3003166194
    Product Code
    QFG
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    January 30, 2026
    Posted
    March 24, 2026
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

    Reason

    Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

    Action

    On 01/30/2026, the firm emailed an initial "URGENT MEDICAL DEVICE CORRECTION" Letter to customer informing them of two issues affecting the MiniMed 780 Insulin Pump Model MMT-1884 that contain software version 6.60 and 6.61. The issues are: 1-Pump Error 53 which indicates that insulin delivery is being stopped. 2-Blood Glucose (BG) Check functionality may not conduct verification/performance checks. Due to a software anomaly, this verification may not occur as expected when the SG reading is above 400 mg/dL or below 50 mg/dL. On 02/20/2026, an "UPDATED: URGENT MEDICAL DEVICE CORRECTION" letter via email informing customer of a third issue discovered with the implementation of software version 6.62, Critical Pump Error (Open Book Image) which may stop insulin delivery. Customers are instructed to: If using Pump Software Ver 6.60 or 6.61: 1. Ensure MiniMed" Mobile app is updated to version 3.1.1 (iOS) and 3.1.2 (Android) or higher. If it is not, complete that update. Click Here for instructions on updating your app. Note: To identify your current Mobile App version, Go to Menu (top left), tap on About . 2. Update MiniMed" 780G insulin pump software to version 6.62. Click Here to refer to the detailed software update guide and update your pump software. Note: For instructions on how to find your pump software version, Click Here. 3. If customer is wearing the Instinct sensor during the update to software version 6.62, immediately restart the Instinct sensor. If customer has already updated to Pump Software Ver 6.62: 1. if wearing an instinct sensor, unpair and re-pair sensor for uninterrupted therapy For assistance with updating MiniMed" Mobile app to the latest version or your insulin pump software to version 6.62, or or experiencing Critical Pump Error (Open Book Image), any questions about the process, please contact 24-Hour Technical Support Team at 1-800-646-4633, option 1.

    Distribution

    Worldwide - U.S. Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Israel.

    Quantity

    26,851 pumps