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Medium risk Drugs & MedicationsClass II

Medtronic MiniMed, Inc. Recall

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

Updated February 13, 2026

Medtronic MiniMed, Inc. is recalling Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722). 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.

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

What is recalled

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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
Drugs & Medications
Recall ID
fda-Z-1749-2026
Classification
Class II
Recalled
February 13, 2026
Read the official notice

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