Diabetes clinic software recalled over incorrect sensor glucose graph data
Medtronic MiniMed is recalling 12,126 CareLink Clinic installations because a software error displays incorrect data on the 24-hour sensor glucose overview graph.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: therapy decisions based on an incorrect glucose graph may lead to hypoglycemia or hyperglycemia, and no injuries are reported.
Plain-English summary
CareLink Clinic, REF MMT-7350, software version 4.2B, from Medtronic MiniMed, is being recalled.
A software error causes incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph. Medtronic states that any potential therapy decisions made based on the incorrect data displayed on that graph may lead to hypoglycemia or hyperglycemia.
The recall covers 12,126 units carrying UDI-DI 0763000B00008748K. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
Clinicians use this graph to adjust diabetes therapy, so a display error can carry into dosing decisions. The enforcement record reports no injuries. Sites running version 4.2B should follow Medtronic's instructions.
The recalled product
- Product
- CareLink Clinic, REF: MMT-7350
- Manufacturer
- Medtronic MiniMed, Inc.
- Affected units
- 12,126
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
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