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
- 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143 +12 more
- 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
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.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US states listed in the recall
- Pumps affected: Paradigm, 600-series, BLE 700-series
- No injuries or incidents reported
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Safety Guide
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