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# Synaptive Medical Recalls BrightMatter Guide
- URL: https://www.fdaweb.com/synaptive-medical-recalls-brightmatter-guide/
- Published: 2018-11-27T12:00:00.000Z
- Updated: 2026-09-15T00:46:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142905

Synaptive Medical has recalled its BrightMatter Guide with SurfaceTrace Registration due to a software defect that could potentially result in serious or life-threatening patient harm. An FDA[ recall notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm626734.htm?ref=fdaweb.com) says that when the device is used with a specific third-party port (the NICO BrainPath device), a software defect may be triggered which affects the system’s display and prevents the surgeon from being able to accurately see the location of surgical tools in the patient’s brain. “In the event this software defect occurs, the surgeon could potentially damage the patient’s brain and vascular structures,” the notice says.