BrightMatter Guide Software 1.3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00670082000078), received between May 23, 2017 and May 23, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K153281); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2017Device Handling Problem; Device Handling Problem

  A SITE REPRESENTATIVE REPORTED THAT DURING THE PROCEDURE BRIGHTMATTER GUIDE HAD LED THE SURGEON TO BELIEVE THAT HE WAS AT THE SITE OF THE TUMOR, SO HE PROCEEDED WITH RESECTION. HOWEVER, POST-OPERATIVE PATHOLOGY RESULTS INDICATED THAT THE TISSUE WAS HEALTHY BRAIN TISSUE. A SECOND PROCEDURE WAS THEN SCHEDULED FOR THE PATIENT. POST-OPERATIVE PATHOLOGY RESULTS INDICATED THAT THE TISSUE WAS GRADE 1 MENINGIOMA. DURING BOTH PROCEDURES, ANATOMICAL LANDMARKS WERE USED FOR REGISTRATION USING THE SAME SYSTEM. NO PATIENT HARM, OR DEATH WAS OBSERVED DURING THE PROCEDURES.

  Patient problems: Numbness

  MAUDE report 6584291 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153281. One submission often covers many models, so check the product and lot details in each record.

• Z-0470-2019 · Oct 9, 2018 · Terminated
  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 attachin