Medtronic CareLink iPro Software Recall for Time Conversion Error
Medtronic is recalling CareLink iPro Therapy Management Software version 1.12 because a time conversion error may cause incorrect reports for data uploaded between September 23 and 27, 2017.
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 hazard involves incorrect data reporting due to a software error, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate category for minor labeling or functional errors without reported harm.
Plain-English summary
Medtronic Inc. is recalling the CareLink iPro Therapy Management Software, model MMT-7340, version 1.12. This software is intended to be used by healthcare professionals with the iPro2 CGM System to upload glucose sensor data, capture blood glucose meter readings, and generate reports for diabetes clinical assessment and therapy optimization.
The recall is due to a time conversion error in the new CareLink iPro Uploader feature. This error may result in incorrect reports for data uploaded from the iPro2 recorder. The issue pertains only to reports generated between September 23, 2017, and September 27, 2017, that used the new uploader feature.
The recall involves 488 uploads and has a worldwide distribution pattern, including the United States. Healthcare professionals using the software should be aware that reports generated during the specified dates may contain inaccuracies due to the time conversion error.
The recalled product
- Product
- Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink…
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Software
- Affected units
- 488
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)
- Version 1.12
Distribution
Distribution scope not specified by the agency.
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