Medtronic MiniMed recalls CareLink Clinic software version 4.4A over incorrect insulin setting calculations
The Settings Calculator in CareLink Clinic software version 4.4A does not use custom values entered by healthcare professionals, so it gives incorrect rapid-acting insulin settings and a patient could get higher or lower insulin doses than needed.
What to do
The notice does not give instructions. Read the official notice for details.
Recall details
- Product
- CareLink Clinic, REF: MMT-7350
- Company
- Medtronic MiniMed, Inc.
- Hazard
- 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…
- Units
- 1
- Where sold
- US Nationwide distribution in the state of KS.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 21, 2026
- Recall started
- September 11, 2026
- FDA enforcement report
- October 28, 2026
- Identifiers
- Codes: UDI-DI: 0763000B00008748K. Software Versions: 4.4A Software Available: US: Between June 4th, 2026, and June 8th, 2026.
- FDA recall number: Z-0203-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- CareLink Clinic, REF: MMT-7350
- Reason for recall
- 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).
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide distribution in the state of KS.
- Quantity
- 1
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