HIGH

Medtronic MiniMed CareLink Clinic Recall 12,126 Units Worldwide in 2025

Medtronic MiniMed recalled 12,126 CareLink Clinic units worldwide after a software error misdisplays the 24-hour Sensor Glucose Overview Graph. The faulty software could prompt clinicians and patients to make therapy decisions based on incorrect glucose data. Patients should stop using the device immediately and contact Medtronic MiniMed or their healthcare provider for instructions.

Quick Facts at a Glance

Recall Date
October 21, 2025
Hazard Level
HIGH
Brand
Medtronic MiniMed
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

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

CareLink Clinic is used to review CGM data and support diabetes management. It integrates with Medtronic MiniMed systems and helps clinicians adjust therapy based on CGM readings.

Why This Is Dangerous

A software error can misrepresent the 24-hour glucose graph. Health decisions based on faulty data can cause hypo or hyperglycemia and associated health risks.

Industry Context

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

Real-World Impact

The error could affect treatment decisions across a global user base, potentially impacting patient safety and treatment outcomes. Immediate action matters to minimize risk.

Practical Guidance

How to identify if yours is affected

  1. Check if your CareLink Clinic device is MMT-7350.
  2. Verify UDI-DI: 0763000B00008748K.
  3. Check software version: 4.2B.
  4. Confirm whether your CGM data might have been influenced by the error.

Where to find product info

Look for the UDI, software version, and device label on the CareLink Clinic hardware or software interface. Review the recall notice for exact identifiers.

What timeline to expect

Refund or replacement processing typically takes 4-6 weeks after submission, though timelines vary by case.

If the manufacturer is unresponsive

  • Document all communications with Medtronic Medical Support.
  • Escalate to your healthcare provider or patient advocacy groups if responses are slow.
  • Consider contacting the FDA if you believe you are not receiving timely remediation.

How to prevent similar issues

  • Keep devices up to date with manufacturer software updates.
  • Verify critical data with alternate readings when decisions may be made.
  • Monitor for official recall notices and promptly implement guidance.
  • When buying new devices, verify software version compatibility and update status.

Documentation advice

Save the recall notice, note the device model and serial/UDI, keep a log of communications with the manufacturer and provider, and document any therapy decisions affected by the faulty data.

Product Details

UDI-DI: 0763000B00008748K Software Versions: 4.2B Sold worldwide, including US states listed in the recall notice US clinical sale window: August 21, 2025 to October 04, 2025 OUS clinical sale window: September 11, 2025 to October 04, 2025 Price: Not disclosed

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Quantity recalled: 12,126
  • UDI-DI: 0763000B00008748K; Software Version: 4.2B
  • Recall date: 2025-10-21
  • Status: Active
  • Hazard: Software error mis-displays glucose data on 24-hour overview graph
  • Geography: Worldwide distribution; US states listed; OUS countries listed

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
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI-DI: 0763000B00008748K
Software Version: 4.2B
Affected States
ALL
Report Date
December 3, 2025
Recall Status
ACTIVE

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