Recall Z-1238-2026 ยท OZP Automated Insulin Dosing Device System, Single Hormonal Control
Medtronic MiniMed, Inc.
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 select
| Date | Feb 2, 2026 (initiated Nov 2, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| 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 |
| Quantity | 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, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The country of Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251032 | MiniMed 780G insulin pump Medtronic Minimed, Inc., Jul 1, 2025 |