MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is
FDA device recall Z-1238-2026 · posted 2026-02-02 · Open, Classified
Recall details
- Recalling firm
- Medtronic MiniMed, Inc.
- Reason for recall
- 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 taken
- 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.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- OZP
- Quantity affected
- 577 units
- 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
- Date initiated
- 2025-11-02
- Date posted
- 2026-02-02
- Location
- Northridge, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MiniMed 780G insulin pump (K251032) | Medtronic Minimed, Inc. | 2025-07-01 |