# FDA recall Z-0470-2019

> **Synaptive Medical Inc** · Class I · device recall initiated 2018-10-09.

## Product

BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2    Product Usage:  BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.

## Reason for recall

This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.

## Distribution

Worldwide - US Nationwide Distribution and the country of Canada

## Key facts

- **Recall number:** Z-0470-2019
- **Recalling firm:** Synaptive Medical Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-09
- **Report date:** 2018-12-05
- **Termination date:** 2021-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toronto, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0470-2019

## Citation

> AI Analytics. FDA recall Z-0470-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0470-2019. Source: US FDA. Licensed CC0.

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