CareLink Clinic (Medtronic) – Graph Data Inaccuracy (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CareLink Clinic, REF: MMT-7350
Brand
Medtronic MiniMed, Inc.
Lot Codes / Batch Numbers
UDI-DI: 0763000B00008748K. Software Versions: 4.2B Software Available: US: Between September 4th, 2025, and October 3rd, 2025. OUS: Between September 11th, 2025, and October 4th, 2025. US (Clinical): Between August 21st, 2025, and October 3rd, 2025. OUS (Clinical): Between August 21st, 2025, and October 4th, 2025.
Products Sold
UDI-DI: 0763000B00008748K. Software Versions: 4.2B Software Available: US: Between September 4th, 2025, and October 3rd, 2025. OUS: Between September 11th, 2025, and October 4th, 2025. US (Clinical): Between August 21st, 2025, and October 3rd, 2025. OUS (Clinical): Between August 21st, 2025, and October 4th, 2025.
Medtronic MiniMed, Inc. is recalling CareLink Clinic, REF: MMT-7350 due to Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 10/21/2025, "URGENT MEDICAL DEVICE CORRECTION" notices were emailed to customers informing them of the following: software version 4.2C was released to correct the issues with the data displayed on 24-hour Sensor Glucose Overview graph. If you made individual diabetes treatment recommendations to patients based on the hypoglycemic patterns or on the 30-day sensor glucose data displayed on the 24-hour Sensor Glucose Overview graph with affected software, revisit those recommendations utilizing patients individual CareLink reports, as they were not impacted by this issue. Complete and return the confirmation form: https://info.medtronicdiabetes.com/carelink-clinic-dashboard-hcp or email form to rs.safetyinformation@medtronic.com For questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option 9.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
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