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.
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.
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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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.
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.
This recall is not described as part of a broader industry pattern.
The error could affect treatment decisions across a global user base, potentially impacting patient safety and treatment outcomes. Immediate action matters to minimize risk.
Look for the UDI, software version, and device label on the CareLink Clinic hardware or software interface. Review the recall notice for exact identifiers.
Refund or replacement processing typically takes 4-6 weeks after submission, though timelines vary by case.
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.
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
No injuries or incidents have been reported.
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