Medtronic MiniMed, Inc. recalls CareLink Clinic

Recalling company

Medtronic MiniMed, Inc.

Product

CareLink Clinic, REF: MMT-7350

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 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 – may cause temporary or medically reversible health consequences

Recall date

Sep 11, 2026

Reported

Oct 28, 2026

Distribution

US Nationwide distribution in the state of KS.

Status

Ongoing

Quantity

1

Lot / codes

UDI-DI: 0763000B00008748K. Software Versions: 4.4A Software Available: US: Between June 4th, 2026, and June 8th, 2026.

Company location

Northridge, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-0203-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0203-2027 in the FDA Enforcement Report. Also see FDA recall press releases.