The Recall Desk
ModerateFDA (Devices)·Z-2898-2016·Announced 2016-10-05

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.

What this means for you

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 c
Manufacturer
Medtronic Inc.
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

Distributed nationwide across the United States.

The notice also names 3 states specifically: