Official recall record
CareLink Clinic, REF: MMT-7350 (ref Z-0203-2027)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-09-11
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Medtronic MiniMed, Inc.
What the authority reported
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).
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-11-13.
Other recalls from this brand
- 2026-09-02 · US FDA — Medical Devices
Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (An - 2026-08-20 · US FDA — Medical Devices
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Pro - 2026-07-13 · US FDA — Medical Devices
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
All 32 official recall notices naming Medtronic MiniMed, Inc. on this site →