Recall Z-0203-2027 ยท PHV Continuous Glucose Monitor Retrospective Data Analysis Software
Medtronic MiniMed, Inc.
CareLink Clinic, REF: MMT-7350
| Date | Oct 21, 2026 (initiated Sep 11, 2026) |
| Status | Open, Classified |
| Reason | 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 pati |
| Root cause | Software design |
| Action | On 9/11/2026, correction notices were mailed to the health care professional, and customer asking them to do the following: The Customer was asked to do the following: Immediately contact your Healthcare Provider (HCP) to confirm your insulin settings values. Complete and return the confirmation form by visiting https://info.medtronicdiabetes.com/FA1587 The health care professional was asked to do the following: If you provided diabetes treatment recommendations to patients based on custom Total Daily Dose(TDD) or long-acting insulin values entered into the CareLin Clinic Settings Calculat |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.