Medtronic Minimed, Inc.: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Recall Summary Medtronic MiniMed insulin pumps (including the 620G model and other series) can deliver too much or too little insulin depending on whether the pump is positioned above or below the infusion site on the body, due to gravity affecting pressure in the pump system. Excess insulin delivery can cause dangerously low blood sugar, while insufficient delivery can cause dangerously high blood sugar, both of which can result in serious health complications or death. The affected pumps have been distributed worldwide, including throughout all U.S. states and territories.

Recalling firm: Medtronic MiniMed, Inc.
Product: MiniMed 620G Insulin Pump (MMT-1750)
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/25b87a12-1e64-4b43-b9c4-ee48d23aff36