BrightMatter Guide — Class I medical device recall Z-0470-2019
Terminated recall by Synaptive Medical Inc, reported 2018-12-05, distributed nationwide. This recall has been initiated due to a software defect found in the Guide System software when used with NICO
| Recall number | Z-0470-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synaptive Medical Inc, Toronto, N/A, Canada |
| Recall initiated | 2018-10-09 |
| Classified | 2018-11-26 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2021-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 37 units |
| Reason classes | software |
| Serial numbers | 0003CZDRLC2, 006317B8562, 006318XYK32, 006348M5562, 00634BBD062, 00634DBD062, 00634X19562, 006358Q2Z52, 00635F48562, 00635GTYK32, 00635NWPK12, 00635YH8562, 006360JV462, 00636L48562, 00637BP9562, 006384WYK32, 00638HTZK32, 00638J89562, 006395Q2Z52, 0063C2SKH72, 0063CPBRM12, 0063DD8GP12, 0063DKWYK32, 0063DZPGP12, 0063F1Q2Z52 and 12 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0470-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.