Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
CareLink Clinic, REF: MMT-7350
Medtronic MiniMed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic MiniMed, Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- CareLink Clinic
- REFMMT-7350
- Lot codes and dates
- UDI-DI0763000B00008748K
- Software Versions4.4A
- Software Available
US: Between June 4th2026and June 8th2026
- Amount recalled
- 1
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- KS
Why it was recalled
CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the system-recommended values, resulting in incorrect rapid-acting insulin parameters. If an HCP or patient inputs these incorrect setting values into the patient's MiniMed Go app, the patient could deliver higher or lower insulin doses compared to their insulin needs, potentially leading to over/under delivery of insulin with a severity ranging from Catastrophic (death from severe hypoglycemia) to Minor (self-treatable hypoglycemia/hyperglycemia).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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