NeuroBlate® System 20985Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816589021097), received between Aug 25, 2022 and Mar 9, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023 BY THE PHYSICIAN THAT THE PATIENT HAD A BLEED POST-OPERATION ON THE SAME DAY OF THE LITT PROCEDURE. THE BLEED WAS CODED AS URGENT AS IT WAS CLASSIFIED AS A HEMATOMA. THE PHYSICIAN WAS UNCERTAIN ON HOW THE BLEED OCCURED, HOWEVER, THEY SPECULATED THAT IT MAY POTENTIALLY BE CAUSED BY THE BIOPSY PERFORMED PRIOR TO THE LITT PROCEDURE. AS A RESULT, THE PHYSICIAN PERFORMED SURGERY ON THE PATIENT TO REMOVE THE TISSUE AROUND THE ABLATION AND THE PATIENT WAS TREATED POST OPERATIVELY AFTERWARDS.

  Patient problems: Hematoma

  MAUDE report 16513540 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE SURGEON ACQUIRED A CT TO CONFIRM LASER DELIVERY PROBE TRAJECTORY. THE CT INDICATED INTRACRANIAL HEMORRHAGE, SO THE LITT PROCEDURE WAS ABORTED TO PERFORM A DECOMPRESSIVE CRANIOTOMY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15292847 ↗