Recall Z-1740-2026 ยท OZO Automated Insulin Dosing , Threshold Suspend
Medtronic MiniMed, Inc.
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
| Date | Apr 2, 2026 (initiated Feb 13, 2026) |
| Status | Open, Classified |
| Reason | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions rela |
| Root cause | Device Design |
| Action | On 2/13/2026, communications began via email, SMS, certified postal mail, and in-app push notifications. Correction notices were sent informing customers of the following: User Guides will be updated to include: "It is important to keep the location of your pump stable relative to your infusion site. Do not wear or place your pump more than 14 in (35.5 cm) above your infusion site. Doing so can cause an over-delivery of insulin, which may result in hypoglycemia." User guides that are updated will be available at: https://www.medtronicdiabetes.com/download-library visit https://info.medtronic |
| Quantity | 60,880 |
| Distribution | Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.