Is the recall limited to Paradigm pumps or all Medtronic MiniMed infusion pumps?

The recall covers Paradigm, 600-series, and BLE 700-series pumps across worldwide distribution.

What hazards should I watch for after this recall?

Incorrect insulin delivery can cause severe hypoglycemia or life-threatening hyperglycemia and DKA.

How do I determine if my pump is affected?

Check the model numbers against the list provided by Medtronic and the FDA recall notice.

Will I get a refund or replacement?

Medtronic will provide instructions for refunds or replacements per the recall notice.

What should I do if the device is essential to my diabetes management?

Contact your healthcare provider immediately for guidance and follow the recall instructions.

Where can I find official recall details?

Visit the FDA enforcement report page linked in the recall notice and the Medtronic website.

What about ongoing CGM integration with pumps?

Consult healthcare providers for guidance on continuity of care during the recall process.

How long will refunds/replacements take?

Manufacturers typically estimate 4-8 weeks for processing after proof of return or replacement request.

Should I stop using the pump right away?

Yes. Stop using the device immediately and follow recall instructions.

What information should I document?

Document model numbers, serials, dates of purchase, and all communications with Medtronic.

HIGHFebruary 13, 2026

Medtronic MiniMed Paradigm Insulin Pumps Recalled 73,656 Units Worldwide in 2026

Medtronic MiniMed recalled 73,656 Paradigm insulin pumps sold worldwide, including broad U.S. distribution, after a risk of unintended insulin delivery. The issue affects Paradigm, 600-series and BLE 700-series pumps. It can cause life-threatening highs or lows in insulin delivery. Stop using the device and follow recall instructions immediately.

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 programmable insulin doses continuously to manage diabetes. The Paradigm, 600-series, and BLE 700-series are older Medtronic MiniMed systems used by patients for daily insulin delivery.

Why This Is Dangerous

The device can mis-deliver insulin if its height relative to the infusion site changes, causing potentially dangerous hypo- or hyperglycemia.

Industry Context

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

Real-World Impact

The issue can result in life-threatening events if not addressed promptly. Consumers should stop using affected pumps and follow recall instructions.

Practical Guidance

How to identify if yours is affected

Cross-check device model numbers with the recall list.
Identify pumps as Paradigm, 600-series, or BLE 700-series.
Review packaging and user guides for model identifiers.

Where to find product info

Model numbers and serials are printed on the device label, packaging, or user guide.

What timeline to expect

Refunds or replacements typically take 4-8 weeks after initiation.

If the manufacturer is unresponsive

Document all contact attempts
Escalate to consumer protection agencies if needed
Consult a lawyer if injuries occur or the company remains unresponsive

How to prevent similar issues

Verify recall status before purchasing insulin pumps
Ask healthcare providers about safer current-generation devices
Keep documentation ready for recalls and returns

Documentation advice

Keep packaging, receipts, device serial numbers, model numbers, and all correspondence with Medtronic for the recall process.

Product Details

Model numbers include 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143, 763000258344, 763000317140, 763000404567, 763000317188, 763000317195, 763000367046, 763000317157, 00613994470492, 00643169496262, 643169577664, 643169577688, 643169577695. Sold worldwide with US distribution noted. No price data provided.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

73,656 units recalled
Worldwide distribution including US states listed in the recall
Pumps affected: Paradigm, 600-series, BLE 700-series
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

ELECTRICALPOISONINGLACERATIONSUFFOCATIONOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeInsulin Pump

Product Details

Brand

Medtronic MiniMed

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