CareLink Clinic, REF: MMT-7350
Pending LLM rewrite. Source: FDA_DEVICE Z-0594-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
The recalled product
- Product
- CareLink Clinic, REF: MMT-7350
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 2025
- and October 3rd
- 2025. OUS: Between September 11th
- and October 4th
- 2025. US (Clinical): Between August 21st
- 2025. OUS (Clinical): Between August 21st
- 2025.
Distribution
Distributed nationwide across the United States.
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