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

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,

Official notice
Medtronic MiniMedHealth & Personal CareMedical DevicesMMT-523MMT-723Paradigm REAL-Time Revel Insulin Pump

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 13, 2026
Status
ACTIVE
Severity
9/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medtronic MiniMed
Product type
Insulin Pump
Model numbers
MMT-523, MMT-723, Paradigm REAL-Time Revel Insulin Pump, Paradigm REAL-Time Revel Insulin Pump UG (MP6025306-011A 1)
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 13, 2026

  2. Reported by FDA DEVICE

    April 8, 2026

  3. RecallRadar source check

    April 15, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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

  1. Confirm model numbers MMT-523 or MMT-723.
  2. Check if the pump is from the Paradigm, 600, or BLE 700 series.
  3. 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.

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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

  • 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

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 Details

Model Numbers
MMT-523
MMT-723
Paradigm REAL-Time Revel Insulin Pump
Paradigm REAL-Time Revel Insulin Pump UG (MP6025306-011A 1)
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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