What prompted this recall?

The recall centers on unintended insulin delivery when the pump height relative to the infusion site changes, potentially causing dangerous hypo- or hyperglycemia. 29,074 units are affected globally.

Which models are affected?

Paradigm Real-Time pumps in the MMT-522 and MMT-722 variants, including Paradigm Real-Time and other related series.

How do I know if my device is affected?

Check your pump model against MMT-522 or MMT-722 and consult the recall notice from Medtronic for list of affected UDI/serial numbers.

What should I do if I experience symptoms?

If you notice signs of hypo- or hyperglycemia, seek immediate medical attention and contact your clinician.

Will I get a replacement or refund?

Medtronic will provide instructions on replacement or refund as part of the recall process. Follow their guidance and your clinician’s.

Where can I find more information?

Visit Medtronic’s recall page and the FDA enforcement notice linked to Z-1749-2026.

How long will the replacement process take?

Manufacturers typically advise a 4-8 week window for refunds or replacements, depending on stock.

What about patients relying on this device for daily management?

Consult your clinician for an alternative management plan during the transition.

Can I dispose of the device myself?

Follow local guidelines and the manufacturer’s disposal instructions as part of the recall.

HIGHFebruary 13, 2026

Medtronic MiniMed Paradigm Real-Time Insulin Pump Recalled for 29,074 Units Worldwide (2026)

Q: Should I stop using my pump now?

Yes. Stop using the device and follow the manufacturer’s recall instructions and your clinician’s guidance.

Medtronic MiniMed recalled 29,074 Paradigm Real-Time insulin pumps worldwide. The devices may deliver insulin improperly when the pump is elevated or lowered relative to the infusion site due to gravitational effects. Patients should stop using the pumps immediately and follow recall instructions from the manufacturer and their healthcare provider.

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

Medtronic MiniMed Paradigm Real-Time insulin pumps are wearable devices used for continuous insulin delivery in diabetes management. They are part of a family of infusion pumps designed to automate insulin dosing.

Why This Is Dangerous

The device can over-deliver insulin when elevated and under-deliver when lowered, due to changes in hydrostatic and hydrodynamic pressures. This can lead to severe hypoglycemia or diabetic ketoacidosis and potentially death.

Industry Context

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

Real-World Impact

The risk is life-threatening for some users. The recall affects patients who rely on these pumps for daily management and may require urgent medical oversight during replacement.

Practical Guidance

How to identify if yours is affected

Verify your pump model against MMT-522 or MMT-722.
Locate the device's UDI/serial numbers and compare with Medtronic recall list.
Check recall notification letter from Medtronic or FDA notice on enforcement page.

Where to find product info

Recall notices are available from Medtronic and FDA enforcement reports. Useful identifiers include model number and device documentation.

What timeline to expect

4-8 weeks for refunds or replacements after initiating the recall process.

If the manufacturer is unresponsive

Document all communications with the manufacturer and clinician.
File a complaint with the FDA if the company is non-responsive.
Consider seeking guidance from a medical professional for interim diabetes management.

How to prevent similar issues

Avoid purchasing older Paradigm/600-series pumps; verify recall status before use.
Verify device with manufacturer before starting any replacement plan.
Ask about safer, modern insulin pump systems with updated safety features.

Documentation advice

Keep recall letter, model numbers, serials, photos of device, and all correspondence with manufacturer and clinicians.

Product Details

Models: MMT-522, MMT-722. Affected series: Paradigm Real-Time, MiniMed 600 series, BLE 700 series. Sold worldwide with US nationwide distribution in multiple states. Recall quantity: 29,074 units. Recall date: 2026-02-13. Manufacturer: Medtronic MiniMed, Inc. Price information: Unknown. Sold since: Unknown. Country of origin: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

29,074 units recalled
Models MMT-522 and MMT-722
Worldwide distribution including US states listed
Recall date 2026-02-13
Hazard: unintended insulin delivery due to pump height
No injuries or incidents reported

View Original Recall on FDA - Medical Devices

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Safety Guide

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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