Device recall
CareLink Clinic, REF: MMT-7350
- Recall number
- Z-0203-2027
- Event id
- 99765
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medtronic MiniMed, Inc.
- Report date
- Oct 28, 2026
- Posted
- Oct 21, 2026
- Initiated
- Sep 11, 2026
- Center classification date
- Oct 21, 2026
- Product code
- PHV
- Device type
- Continuous Glucose Monitor Retrospective Data Analysis Software
- 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).
- Root cause
- Software design
- Quantity
- 1
- Code info
- UDI-DI: 0763000B00008748K. Software Versions: 4.4A Software Available: US: Between June 4th, 2026, and June 8th, 2026.
- Distribution
- US Nationwide distribution in the state of KS.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northridge, CA, United States