# FDA recall Z-0407-2019

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2018-10-02.

## Product

Medtronic CareLink Encore 29901 Programmer

## Reason for recall

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0407-2019
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-10-02
- **Report date:** 2018-11-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2019

## Citation

> AI Analytics. FDA recall Z-0407-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0407-2019. Source: US FDA. Licensed CC0.

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