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

Recall Summary Medtronic MiniMed insulin pumps (640G and earlier models) 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 can cause dangerously low blood sugar, while insufficient insulin can cause dangerously high blood sugar, and both conditions can lead to serious complications or death. The affected pumps have been distributed worldwide, including throughout the United States and many other countries.

Recalling firm: Medtronic MiniMed, Inc.
Product: MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
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/01998cd6-a2f8-4815-8e91-a42b16f9dcd6