Medtronic Minimed, Inc.: Automated Insulin Dosing Device System, Single Hormonal Control

Recall Summary Medtronic MiniMed 770G insulin pumps are being recalled worldwide because they can deliver too much or too little insulin when the pump is positioned higher or lower than the infusion site on the body. Excessive insulin delivery can cause dangerously low blood sugar, seizures, or loss of consciousness, while insufficient delivery can cause dangerously high blood sugar and diabetic complications. The recall affects pumps distributed across the US, Canada, Europe, Asia, Latin America, and other regions.

Recalling firm: Medtronic MiniMed, Inc.
Product: MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
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...
Classification: Class III
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-02-13
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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...

Recall details on Nibble Recalls: https://trynibble.app/recalls/4256fd32-18a2-4b81-91bf-7ecc9d7f8c26