FDA recall, , Moderate risk
Medtronic CareLink Clinic
CareLink Clinic software has a defect that can lead to incorrect insulin doses.
Summary by Recall Canary from the FDA notice
What happened
Medtronic MiniMed, Inc. is recalling CareLink Clinic, REF MMT-7350, software version 4.4A, because a defect in the Settings Calculator feature fails to use custom values entered by healthcare professionals for Total Daily Dose or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor, and Max Recommended value for Rapid-acting insulin.
The company began the recall on September 11, 2026, and it was added to the FDA's Enforcement Report on October 21, 2026. The product was distributed in Kansas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
CareLink Clinic
- UDI-DI
- 0763000B00008748K
- 4.4A
- Reference number
- MMT-7350
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Kansas.
- Company
- Medtronic MiniMed, Inc.
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99765
- Recall number
- Z-0203-2027
All recalls from Medtronic MiniMed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
