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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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-522, MMT-722, Paradigm Real-Time Insulin Pump
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 13, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
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
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.
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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
- Models MMT-522 and MMT-722
- Worldwide distribution including US states listed
- Hazard: unintended insulin delivery due to pump height
- No injuries or incidents reported
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Safety Guide
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