Medtronic MiniMed recalls its insulin pumps over delivery errors tied to pump height

On February 13, 2026, Medtronic MiniMed, Inc. began telling customers by email, text message, certified mail and in-app notification that its insulin pumps can deliver too much or too little insulin depending on where the pump sits relative to the infusion site.[1] The FDA posted the action on April 2, 2026, and classified it as a Class II recall.[1] Medtronic titled its notice to users an "Urgent Medical Device Correction" about pump placement with respect to the infusion site.[3]

What the FDA record says

The issue is how high or low the pump sits compared with the spot where insulin enters the body.[1] According to the FDA, all Medtronic MiniMed infusion pumps in the Paradigm series, the 600 series and the 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."[1] The FDA listed the cause as device design.[1]

The FDA spelled out the risk in both directions. Over-delivery, which can happen when the pump is held above the infusion site, "can result in severe hypoglycemia, altered mental status, seizure, coma, or death."[1] Under-delivery, which can happen when the pump sits below the site, "can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death."[1]

Which pumps and how many

The recall event, number 98186, has 14 product records, one for each pump family.[2] They cover the MiniMed 780G, 770G, 740G, 720G, 700G, 670G, 640G, 630G, 620G and 530G, along with the Paradigm, Paradigm REAL-Time, Paradigm REAL-Time Revel and Paradigm REAL-Time Veo pumps.[2] The 453,144 units in commerce listed on the main FDA record are for the MiniMed 780G alone.[1] Added together, the quantities across all 14 records come to 1,086,165 pumps.[2]

Distribution was worldwide, including nationwide in the US.[1] As of the FDA page we read in October 2026, the recall was still open, which the agency explains as "not all products have been corrected or removed."[1]

What this means for you

Medtronic said its user guides would gain this warning: "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."[1] The firm said updated guides would be available in the Medtronic Diabetes download library.[1]

The correction notice listed these required actions, as the FDA quotes them:[1]

• "Keep the location of your insulin pump close to your infusion site."
• "If you need to raise the pump above your infusion site, such as when a parent or caregiver is using the pump for a child, limit the time that the pump is held above the infusion site."
• "Pay attention to any alerts from your pump as well as symptoms of hypoglycemia and hyperglycemia; follow your healthcare professional's treatment instructions in these situations."
• Complete and return the acknowledgement form at info.medtronicdiabetes.com/pump-placement.

For questions about the notice, the FDA record lists Medtronic 24-Hour Technical Support at 1-855-587-4950.[1] For anything about your insulin, your readings or your pump settings, talk to your care team or pharmacist.

How to check your lot number

This recall isn't limited to certain lots. The FDA describes it as covering all Medtronic MiniMed infusion pumps in the three series, so what matters is your pump's model.[1] Each FDA record names the model numbers it covers, for example MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895 and MMT-1896 for the MiniMed 780G.[1] Compare your pump's model with the product lines in the FDA recall record.[1]

Medtronic's acknowledgement form asks for your pump serial number.[3] On a MiniMed 780G, MiniMed says the serial number is on the back of the pump after the letters "SN" (remove the belt clip to see it), and that it starts with NG.[4] You can also find it on the Pump Status screen, or in your Diabetes.shop account.[4] For the MiniMed 530G and the Paradigm Revel, 522/722 and 515/715 pumps, MiniMed says the serial number follows "SN" on the back of the pump and also shows on the STATUS screen.[5]