BEUDAMED
    FDA Recall Open, Classified

    MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

    Recall: Z-1238-2026 · Initiated November 2, 2025

    Recall

    Recall Number
    Z-1238-2026
    Event Number
    97997
    Firm
    Medtronic MiniMed, Inc.
    FEI Number
    3003166194
    Product Code
    OZP
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    November 2, 2025
    Posted
    February 2, 2026
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

    Reason

    A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.

    Action

    On 11/02/2025, the firm sent an initial "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that an issue was identified which may cause the MiniMed 780G pump to display an alarm indicating insulin delivery is being stopped (Pump error 43 or 41). Customers are instructed to: 1.Respond to all alerts/alarms from your pump. 2.Be prepared to complete the Reservoir & Set procedure after responding to a Pumperror 43 or Pump error 41 alarm. 3.Check that your Alert on High is set during the night or at times when you may not be actively monitoring the pump, making it easier to detect when insulin delivery remains suspended. 4. Keep the pump s audio enabled, making it easier to detect when insulin delivery remains suspended after an alarm is acknowledged. For questions or further assistance, contact Medtronic 24-Hour Technical Support line at 1-800-646-4633, option 1.

    Distribution

    Worldwide - U.S. National distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The country of Israel.

    Quantity

    577 units