Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
BrightMatter Guide Recalled by Synaptive Medical Inc Due to This recall has been initiated due to a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synaptive Medical Inc directly.
Affected Products
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
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synaptive Medical Inc
Synaptive Medical Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report