- Recalling firm
- Medtronic MiniMed, Inc.
- Reason for recall
- 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).
- Affected products (lot / model / serial)
- UDI-DI: 0763000B00008748K. Software Versions: 4.4A Software Available: US: Between June 4th, 2026, and June 8th, 2026.
- Units affected
- 1
- Distribution pattern
- US Nationwide distribution in the state of KS.
- Firm location
- Northridge, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0203-2027
- Recall initiated
- September 11, 2026
- FDA classification date
- October 21, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99765
- Last updated on HTM Vibe
- November 3, 2026
