Medtronic Recalls CareLink iPro2 Reports Due to Time Zone Error
Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because they used the wrong time zone, causing inaccurate timestamps for continuous glucose data.
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 involves a software error resulting in inaccurate data timestamps (time zone mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity issue involving data integrity or minor labeling/reporting errors.
Plain-English summary
Medtronic MiniMed Inc. is recalling 19 CareLink iPro Therapy Management reports (Model No. MMT-7340). These software reports are intended to retrospectively calibrate sensor data and provide continuous glucose information. The recall is limited to reports distributed in Minnesota.
The recall is being issued because the CareLink iPro2 Professional CGM data uploading process applied the Pacific Standard Time zone as the time reference. However, the patients and their sensor data were subject to the Central Standard Time zone. This error resulted in inaccurate time zones being applied to the 19 affected reports.
Consumers who have received these specific CareLink iPro Therapy Management reports should contact Medtronic MiniMed for further instructions. The source text does not specify a direct health hazard or reported injuries associated with this software error.
The recalled product
- Product
- CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
- Manufacturer
- Medtronic MiniMed Inc.
- Category
- Medical Device — Software
- Affected units
- 20
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
Distributed in 1 state:
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