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Medtronic MiniMed 630G Insulin Pumps Recalled in 2026 for Insulin Delivery Errors (60,880 Units)

Medtronic MiniMed recalled 60,880 insulin pumps sold worldwide through healthcare providers and medical distributors, including the MiniMed 630G line. The defect is gravity related and can cause insulin over-delivery or under-delivery when the pump height changes relative to the infusion site. Patients should stop using the pumps immediately and follow recall instructions.

Official notice
Medtronic MiniMedHealth & Personal CareMedical DevicesPump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066643169752726763000101527

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
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169873841, 643169878648 +7 more
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

The MiniMed 630G insulin pump is a wearable device that delivers insulin to manage diabetes, typically used with continuous glucose monitoring systems for automated delivery.

Why This Is Dangerous

The pump can deliver incorrect insulin doses when its height relative to the infusion site changes. Gravity affects pressures, leading to over-delivery or under-delivery.

Industry Context

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

Real-World Impact

The recall affects tens of thousands of devices worldwide. Consumers must stop using affected pumps and follow guidance from Medtronic and clinicians.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers MMT-1714, MMT-1715, MMT-1754, MMT-1755.
  2. Review whether your pump was part of the recalled lot by consulting Medtronic or your clinician.
  3. Inspect pump height during use relative to infusion site.

Where to find product info

Recall notice and user guides from Medtronic and the FDA recall page list the affected models and steps.

What timeline to expect

Refunds or replacements follow Medtronic's recall process; timelines vary by locale.

If the manufacturer is unresponsive

  • Escalate to Medtronic customer support.
  • File a complaint with the FDA if the company is unresponsive or addresses are not provided.

How to prevent similar issues

  • Avoid using affected pumps; ensure replacement devices are properly configured.
  • Stay updated on firmware or software updates if applicable.
  • Verify device and infusion site setup per clinician guidance.

Documentation advice

Keep the recall notice, model numbers, purchase records, and all correspondence with Medtronic for your records.

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Product Details

Model numbers: MMT-1714, MMT-1715, MMT-1754, MMT-1755. Product: MiniMed 630G Insulin Pump. Sold worldwide through healthcare providers and medical distributors. Sold since the MiniMed 630G line was in use prior to the recall. Price: Not disclosed.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Worldwide distribution including US states and many countries
  • Models affected include MMT-1714, MMT-1715, MMT-1754, MMT-1755
  • Immediate-use stop required; follow recall instructions

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
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066
643169752726
763000101527
763000190446
763000317591
+10 more
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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