# FDA recall Z-0843-2021

> **Medtronic Inc.** · Class II · device recall initiated 2020-11-12.

## Product

CareLink Personal Software Therapy Management Software Tool for Diabetes  CareLink System Therapy Management Software Tool for Diabetes    Software Uploader versions:  3.1.5.000  3.1.2.000

## Reason for recall

Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy.  During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.

## Distribution

U.S. Nationwide    O.U.S. Worldwide    Refer to Associated Documents and uploaded Consignee Lists/Spreadsheets.  -Australia New Zealand  -Canada  -EMEA  -Greater China  -India  -Japan  -Latin America  -South Korea  -Southeast Asia  -US

## Key facts

- **Recall number:** Z-0843-2021
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-12
- **Report date:** 2021-01-20

- **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-0843-2021

## Citation

> AI Analytics. FDA recall Z-0843-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0843-2021. Source: US FDA. Licensed CC0.

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