Class I — Synaptive Medical Inc
| Recalling firm | Synaptive Medical Inc |
|---|---|
| Registered facility | Synaptive Medical Inc (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 37 units |
| Distribution | Worldwide - US Nationwide Distribution and the country of Canada |
| Initiated | 2018-10-09 |
| Classified | 2018-11-26 |
| Terminated | 2021-08-12 |
| Recall number | Z-0470-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Synaptive Medical Inc (Z-0470-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81317/
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