Medtronic Recalls CareLink iPro Software Due to Time Stamp Error
Medtronic is recalling CareLink iPro Version 1.10 software due to a time stamp error. The recall affects 33 units distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect is a time stamp error, which is a software malfunction rather than a direct physical hazard like a fire or choking risk. No injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software, Version 1.10, Catalog No. MMT-7340. The recall is being conducted due to a time stamp error in the software. This software is used to retrospectively calibrate sensor data from the iPro2 recorder and blood glucose meter to provide reports of continuous glucose information.
The recall involves 33 units of the software. Distribution was nationwide, with specific mentions of Tennessee, Minnesota, and Washington. The source text does not specify any reported illnesses, injuries, or deaths associated with this defect.
Consumers and healthcare providers who have this specific version of the software should contact Medtronic for further instructions on how to proceed. The source text does not provide specific contact details or remediation steps beyond the recall notice itself.
The recalled product
- Product
- CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven…
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 33
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 (1)
- n/a
Distribution
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