The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Synaptive Medical, Inc. BrightMatter Guide with SurfaceTrace Registration
- Model/Product Numbers: SYN-0026 (Versions: 1.5.0, 1.5.1 and 1.5.2)
- Manufacturing Dates: November 17, 2017 to April 24, 2018
- Distribution Dates: April 10, 2015 to July 27, 2018
- Devices Recalled in the U.S.: 36
Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration provides detailed three-dimensional (3D) images of a patient’s brain to help surgeons safely navigate surgical tools used during brain surgery.
Reason for Recall
Synaptive Medical has initiated this recall due to a software defect found in the BrightMatter Guide System’s software that could potentially result in serious or life-threatening patient harm.
When the BrightMatter Guide System is used with two configurations of a specific third-party port (the NICO BrainPath device), a software defect may be triggered upon switching between the configurations 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.
Who May be Affected
- Surgeons and other trained medical personnel using Synaptive’s BrightMatter Guide with SurfaceTrace Registration to perform neurosurgical procedures.
- Patients undergoing a neurosurgical procedure using Synaptive’s BrightMatter Guide with SurfaceTrace Registration.
What to Do