Medtronic MiniMed CareLink Clinic software recalled for insulin dosing calculation error
What this means
Medtronic MiniMed CareLink Clinic software version 4.4A has a defect in its Settings Calculator feature. When healthcare providers enter custom insulin values, the calculator ignores them and continues using default values instead. This can result in incorrect insulin dose recommendations being sent to patients' insulin pumps, potentially causing patients to receive too much or too little insulin.
- If you use CareLink Clinic software version 4.4A, contact Medtronic or your healthcare provider immediately
- Do not rely on insulin calculations from the Settings Calculator in version 4.4A until you receive an update
- Monitor your blood glucose closely and follow your healthcare provider's dosing instructions
The agency's original wording
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2027More Medtronic recalls
- FDA-Device2026-10-22Medtronic MiniMed Go App version 1.2.1 recalled for failed insulin dose reminders
- FDA-Device2026-10-14Medtronic MiniMed Flex insulin pump recalled for failed quality verification tests
- FDA-Device2026-08-26Medtronic MiniMed 640G insulin pump loaner units recalled for potential malfunction from incompatible cleaning
- FDA-Device2026-08-26Medtronic MiniMed 670G insulin pump loaner units recalled for damage risk and insulin delivery failure
- FDA-Device2026-08-26Medtronic MiniMed 780G insulin pump loaner units recalled for potential moisture damage and insulin delivery failure
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