Medtronic Minimed, Inc.: Automated Insulin Dosing , Threshold Suspend
Recall Summary Medtronic MiniMed insulin pumps (630G and earlier models) are being recalled 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 severe low blood sugar leading to seizures, loss of consciousness, or death, while insufficient delivery can cause severe high blood sugar and diabetic emergencies. The recall affects pumps distributed worldwide, including throughout the United States.
- Recalling firm
- Medtronic MiniMed, Inc.
- Product
- MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/68cd6cca-1956-48ac-b16e-6bbe80a183d9