Recall Z-0203-2027— Medtronic MiniMed, Inc.

Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2026-09-11. FDA's recall record names no specific 510(k) clearance for this event. 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)..

Recalling firm

Medtronic MiniMed, Inc.

Classification

Class II

Status

Ongoing

Initiated

2026-09-11

Firm location

Northridge, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.