TemporaryFDAOngoing
Can cause harm that is usually temporary.
CareLink Clinic, REF: MMT-7350
Check the device or its packaging for
UDI-DI: 0763000B00008748K. Software Versions: 4.4A Software Available: US: Between June 4th, 2026, and June 8th, 2026.
- Why
- 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).
- Distributed
- US Nationwide distribution in the state of KS.
- Company
- Medtronic MiniMed, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0203-2027 · retrieved 21 October 2026
Read the official notice