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High risk Medical DevicesClass II

Medtronic MiniMed Paradigm Pump Insulin Recall

Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

Updated February 13, 2026

Medtronic MiniMed Paradigm REAL-Time insulin pumps can deliver too much or too little insulin depending on how the pump is positioned relative to the infusion site, causing dangerous swings in blood sugar. Elevated pump position risks severe low blood sugar; lowered position risks severe high blood sugar and diabetic emergency.

Is the Medtronic MiniMed, Inc. recalled? Yes. This product was recalled by FDA on February 13, 2026. Details below.

What is recalled

Medtronic MiniMed Paradigm REAL-Time Insulin Pump models MMT-522 and MMT-722. The issue also affects Medtronic MiniMed 600 series and BLE 700 series infusion pumps.

Am I affected

You are affected if you use a Medtronic MiniMed Paradigm REAL-Time Insulin Pump (model MMT-522 or MMT-722), a Medtronic MiniMed 600 series pump, or a Medtronic MiniMed BLE 700 series pump.

What to do right now

Contact Medtronic MiniMed immediately to discuss the positioning risk and receive guidance on pump use and monitoring. Do not assume your current pump positioning is safe. Work with your healthcare provider and Medtronic to establish safe positioning practices or explore replacement options.

The hazard

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 relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Brands affected

Medtronic MiniMed, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1749-2026
Classification
Class II
Recalled
February 13, 2026
Read the official notice

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