December 4, 2018

FDA: Class I recall of Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration

By: Judy Mathias

Editor’s Note

The Food and Drug Administration (FDA) on November 30 identified the recall by Synaptive Medical of its BrightMatter Guide with SurfaceTrace Registration, which is used to perform neurosurgical procedures, as Class I, the most serious.

The recall was initiated because of a software defect that could potentially result in serious or life-threatening patient harm.

When the BrightMatter Guide System is used with two configurations of a third-party port (the NICO BrainPath device), a software defect may be triggered when switching between configurations, which affects the display and prevents the surgeon from accurately seeing the location of surgical tools in the patient’s brain.

Manufacturing dates for the device are November 17, 2017 to April 24, 2018.


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