Which models are affected?

Affected models include Paradigm REAL-Time Revel insulin pumps with MMT-523 and MMT-723 identifiers. The recall covers pumps from the Paradigm series, 600 series, and BLE 700 series.

What should I do if I own one of these pumps?

Stop using the device immediately. Follow the recall instructions from Medtronic MiniMed and contact your healthcare provider for guidance.

Will this recall affect all users of insulin pumps?

The recall specifically targets Paradigm REAL-Time Revel pumps and related Medtronic MiniMed infusion pumps in the cited series.

What are the warning signs of insulin misdelivery?

Over-delivery can cause severe hypoglycemia with dizziness, confusion, seizures, or loss of consciousness. Under-delivery can cause severe hyperglycemia, dehydration, and diabetic ketoacidosis.

Will I receive a replacement or refund?

The notice instructs users to follow the recall instructions. The remedy indicates stopping use and contacting Medtronic MiniMed for instructions; refunds or replacements are not specified in the available information.

How can I identify my pump model?

Check the device labeling for MMT-523 or MMT-723. Refer to the recall letter for additional identifiers and serial data.

What if I can’t reach Medtronic MiniMed?

Consult your healthcare provider for guidance and contact Medtronic MiniMed through the channels provided in the recall notification.

How long will it take to resolve the recall?

The notice does not specify a time frame for remediation or replacement processing.

Where can I find more information?

Refer to the FDA enforcement report linked in the recall and the Medtronic MiniMed recall notice for official guidance.

HIGHFebruary 13, 2026

Medtronic MiniMed Paradigm Revel Insulin Pumps Recalled: 26,647 Units Worldwide (2026)

Q: What is being recalled and why?

Medtronic MiniMed Paradigm REAL-Time Revel insulin pumps are recalled due to a design issue that can cause insulin over-delivery or under-delivery when the pump height changes relative to the infusion site. This can lead to severe hypoglycemia or hyperglycemia, including death.

Medtronic MiniMed recalled 26,647 Paradigm REAL-Time Revel insulin pumps distributed worldwide, including in the United States. A design flaw can cause insulin to be over- or under-delivered when the pump height changes relative to the infusion site. Patients and health providers should stop using the device immediately and follow the manufacturer’s recall instructions. The recall covers Paradigm,

Quick Facts at a Glance

Recall Date: February 13, 2026
Hazard Level: HIGH
Brand: Medtronic MiniMed
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic MiniMed, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

Insulin pumps deliver continuous insulin to people with diabetes. The Paradigm REAL-Time Revel pumps are part of Medtronic MiniMed’s insulin pump lines used with infusion sets.

Why This Is Dangerous

The device may cause insulin to be delivered at incorrect rates when its height relative to the infusion site changes. This can lead to dangerous swings in blood glucose levels and potential life-threatening events.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Users may experience dangerous blood glucose fluctuations. Immediate cessation of use is advised until guidance from Medtronic MiniMed or healthcare providers is obtained.

Practical Guidance

How to identify if yours is affected

Confirm model numbers MMT-523 or MMT-723.
Check if the pump is from the Paradigm, 600, or BLE 700 series.
Review the recall letter for device identifiers and instructions.

Where to find product info

Recall notice, Medtronic MiniMed website, and healthcare provider communications.

What timeline to expect

Not specified in the recall notice.

If the manufacturer is unresponsive

File a complaint with the FDA if applicable.
Consult your healthcare provider for safety guidance and documentation.

How to prevent similar issues

Register for recall updates from the manufacturer.
Have a diabetes care plan ready if you need to switch devices temporarily.
Ask a clinician about safe switching options if you rely on insulin pump therapy.

Documentation advice

Keep the recall notice, pump model numbers, serial numbers, purchase records, and all communications with the manufacturer.

Product Details

Model numbers: MMT-523 and MMT-723. Sold worldwide through healthcare providers and medical suppliers. Sold date and price not specified in the notice.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

26,647 units affected
Worldwide distribution including US states and numerous countries
Over-delivery and under-delivery risk due to pump height relative to infusion site
Immediate stop-use recommendation
Recall notification by letter

View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

9/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeInsulin Pump

Product Details

Feb 13, 2026

Medtronic MiniMed

All Medtronic