Recall Z-1635-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Medtronic MiniMed, Inc.
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
| Date | Mar 24, 2026 (initiated Jan 30, 2026) |
| Status | Open, Classified |
| 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). |
| Root cause | Software change control |
| 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" lett |
| Quantity | 26,851 pumps |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251032 | MiniMed 780G insulin pump Medtronic Minimed, Inc., Jul 1, 2025 |