# FDA recall Z-0670-2018

> **Medtronic Inc.** · Class II · device recall initiated 2017-10-10.

## 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 iPro software is used to upload glucose sensor data stored on a recording device, capture BG meter readings through manual entry or wired-upload, retrospectively calibrate sensor data, and provide retrospective reports of continuous glucose information. The reports generated by the CareLink iPro software are intended for use by healthcare professionals to assist with diabetes clinical assessment, patient education, and therapy optimization.

## Reason for recall

Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature.

## Distribution

Worldwide Distribution - US Distribution

## Key facts

- **Recall number:** Z-0670-2018
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-10
- **Report date:** 2018-02-28
- **Termination date:** 2021-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northridge, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0670-2018

## Citation

> AI Analytics. FDA recall Z-0670-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0670-2018. Source: US FDA. Licensed CC0.

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