NeuroBlate SystemRecalls & reported problems across all models

We found 4 models of NeuroBlate System by Monteris Medical Inc in the FDA's device registry (GUDID). Together they are named in 518 adverse event reports in the FDA's MAUDE database, received between May 26, 2017 and Sep 23, 2026 — classified as 19 deaths, 231 injuries, 268 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (143 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NeuroBlate System problems

NeuroBlate System models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NeuroBlate® System 20980

  Powered laser surgical instrument
  7 deaths296 reports
• NeuroBlate® System 20360

  Powered Laser Surgical Instrument
  11 deaths127 reports
• NeuroBlate® System 20360

  Powered Laser Surgical Instrument
  1 death93 reports
• NeuroBlate® System 20985

  Powered laser surgical instrument
  2 reports

Recent NeuroBlate System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Melted

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874209 ↗
• DeathJun 23, 2026Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN LET MONTERIS KNOW THAT THEIR PATIENT FROM THE UCD-135 CASE ON (B)(6) 2026 HAD RECENTLY PASSED. AFTER THE LITT PROCEDURE ON THAT DATE, PATIENT IMAGING SHOWED SIGNIFICANT EDEMA. THE PHYSICIAN PERFORMED A CRANIOTOMY THAT EVENING OR THE NEXT DAY TO RELIEVE PRESSURE FROM THE EDEMA. THE PHYSICIAN COMMENTED THAT THE WHOLE BRAIN SHOWED SIGNIFICANT EDEMA AND NOT JUST ON THE SITE OF LITT SURGERY, AND THE PATIENT PASSED SHORTLY AFTER THE CRANIOTOMY. EXACT DATE OF DEATH IS UNKNOWN TO MONTERIS.

  Patient problems: Cerebral Edema

  MAUDE report 25599734 ↗
• MalfunctionApr 14, 2026Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE LASER FIBER CONNECTION ON THE PANEL BETWEEN THE ELECTRONICS RACK AND THE PORTABLE CONNECTOR MODULE (PCM) WAS THERMALLY FUSED DURING THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874949 ↗
• MalfunctionApr 3, 2026Radiation Leak

  DURING AN ABLATION PROCEDURE ON (B)(6) 2026, IT WAS REPORTED THAT THE LASER PROBE FAILED TO GENERATE ADEQUATE THERMAL ENERGY. THE LASER FIBER FROM THE PEN PANEL TO THE PORTABLE CONNECTOR MODULE (PCM) WAS REPLACED, BUT NO CHANGE IN PERFORMANCE WAS OBSERVED. THE LASER PROBE ITSELF WAS THEN REPLACED, AFTER WHICH HEAT GENERATION WAS SLIGHTLY IMPROVED, THOUGH IT WAS STILL NOTED TO BE SLOWER THAN EXPECTED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. ON (B)(6) 2026, AN ON-SITE INVESTIGATION WAS PERFORMED AND FIELD PERSONNEL IDENTIFIED A DAMAGE WITH BURN MARKS ON THE PRIMARY LASER FIBER THAT RAN FROM THE ELECTRONICS RACK TO THE MRI ROOM, IMPLYING A POTENTIAL UNWANTED LASER EMISSION DURING THE CASE ON (B)(6) 2026. THE DAMAGED FIBER WAS REPLACED DURING THE ON-SITE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776110 ↗
• MalfunctionFeb 27, 2026Melted

  DURING AN ABLATION PROCEDURE ON (B)(6) 2026, A COOLING ERROR WAS REPORTED THAT PREVENTED INITIAL PROBE COOLING. THE ISSUE WAS RESOLVED BY SWAPPING TO A BACKUP PORTABLE CONNECTOR MODULE (PCM) AND SPARE LASER FIBER CABLE, AFTER WHICH THE CASE PROCEEDED WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED. THE ORIGINAL COMPLAINT WAS EVALUATED AND DETERMINED TO BE NON-REPORTABLE. DURING INVESTIGATION OF THE RETURNED PCMS THAT WAS RECEIVED ON 19-FEB-2026, A MELT WAS IDENTIFIED ON THE LASER CONNECTOR OF ONE OF THE BACKUP PCMS THAT WAS USED TO TROUBLESHOOT THE ISSUE. THE CLINICAL SPECIALIST CONFIRMED THAT THIS MELT WAS NOT RELATED TO THE DESCRIBED COOLING ERROR AS THIS PCM'S LASER CONNECTION WAS NOT CONNECTED TO A PROBE OR USED TO FIRE THE NEUROBLATE LASER FOR THIS CASE. THE MELT WAS IDENTIFIED INCIDENTALLY DURING PRODUCT VISUAL INSPECTION AS PART OF THE ORIGINAL COMPLAINT'S INVESTIGATION. THE IDENTIFIED MELT ON THE PCM LASER CONNECTOR RAISES THE POSSIBILITY OF A POTENTIAL UNINTENDED LASER EMISSION AT AN UNDETERMINED TIME PRIOR TO THE RETURN OF THE DEVICE. NO PATIENT HARM RELATED TO THIS FINDING HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476464 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT AFTER PLACING THE 3.3 SIDEFIRE LASER PROBE AND RUNNING A 3D T1 SCAN, THE PHYSICIAN NOTED THE PRESENCE OF A HEMATOMA. TWO T1 SCANS WERE ACQUIRED APPROXIMATELY 10 MINUTES APART. THE PHYSICIAN COMPARED THE SCANS, OBSERVED GROWTH OF THE HEMATOMA, AND DECIDED TO ABORT THE LITT CASE AND CONVERT TO A CRANIOTOMY TO RELIEVE PRESSURE.

  Patient problems: Hematoma

  MAUDE report 24388815 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REMASTER SAE FORM, IT WAS REPORTED THAT A PATIENT EXPERIENCED A NEW LESION ALONG THE BIOPSY/LITT TRACK. THE PATIENT UNDERWENT A BIOPSY AND LITT PROCEDURE ON (B)(6) 2025 AND AN MRI ON (B)(6) 2025 SHOWED THIS FINDING. THE TREATING PHYSICIAN DEEMED THE NEW LESION AS POSSIBLY RELATED TO THE NEUROBLATE PROCEDURE AND DEFINITELY RELATED TO THE SURGICAL PROCEDURE. THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR THE NEW FINDING, DETAILS NOT AVAILABLE AT THIS TIME.

  Patient problems: Solid Tumor

  MAUDE report 23897499 ↗
• MalfunctionDec 26, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE LASER FIBER CONNECTION AT THE PEN PANEL, WHICH CONNECTS THE LASER FIBER BETWEEN THE PORTABLE CONNECTOR MODULE (PCM) AND THE ELECTRONICS RACK, BECAME THERMALLY FUSED. THE LASER FIBER FROM THE PCM WAS CUT AND A NEW LASER FIBER CONNECTION BETWEEN THE PCM AND ELECTRONICS RACK WAS MADE WITH TWO BACKUP LASER FIBERS THAT WERE ON SITE. THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896592 ↗
• MalfunctionNov 10, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT NO THERMAL HEATING WAS OBSERVED AT THE BEGINNING OF THE ABLATION. THE PROCEDURE WAS PAUSED, AND IT WAS FOUND THAT THE PROBE LASER FIBER HAD BECOME LOOSE, WHICH PREVENTED HEAT FROM TRANSFERRING TO THE PROBE AND CAUSED THERMAL DAMAGE TO THE PROBE LASER FIBER CONNECTOR ON THE PORTABLE CONNECTOR MODULE (PCM). THE LASER FIBER WAS REPLACED WITH A BACKUP AND THE ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513998 ↗
• DeathOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REMASTER SAE FORM, IT WAS REPORTED ON POST-LITT PROCEDURE DAY 18, THE PATIENT PRESENTED TO THE ER DUE TO DECREASED APPETITE AND INCREASED GENERALIZED WEAKNESS. THE PATIENT WAS TOO WEAK TO ATTEND HER ONCOLOGY APPOINTMENT, AND IT WAS RECOMMENDED THAT SHE GO IN. UPON ARRIVAL, HER HEART RATE WAS IN THE 130S, AND HER SYSTOLIC BLOOD PRESSURE WAS 69-78. SHE WAS ADMITTED TO THE ICU FOR HEMODYNAMIC MANAGEMENT. CHEST IMAGING INDICATED MODERATE TO LARGE RIGHT PLEURAL EFFUSION WITH MILD TO MODERATE LAYERING LEFT PLEURAL EFFUSION. BLOOD CULTURE CAME BACK POSITIVE FOR HAEMOPHILUS INFLUENZAE, AND URINE CULTURE WAS POSITIVE FOR KLEBSIELLA PNEUMONIAE. ON POST-STUDY PROCEDURE DAY 27, THE PATIENT REMAINED AFEBRILE AND HEMODYNAMICALLY STABLE. WHITE BLOOD CELL COUNT CONTINUED TO INCREASE, AND CHEST IMAGING SHOWED LARGE RIGHT PLEURAL EFFUSION WITH NEAR COMPLETE COMPRESSIVE ATELECTASIS. CT ALSO SHOWED DILATED STOMACH AND DISTAL SMALL BOWEL WITH DECOMPRESSED COLON SUGGESTIVE OF BOWEL OBSTRUCTION. THE PATIENT REMAINED ON ANTIBIOTICS WITHOUT IMPROVEMENT. ON POST-STUDY PROCEDURE DAY 28, PATIENT HAD A COUGH AND DECREASED SATURATIONS OVERNIGHT. WHITE BLOOD CELL COUNT CONTINUED TO INCREASE WITHOU

  Patient problems: Bacteremia; Urinary Tract Infection

  MAUDE report 23436631 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO THE START OF AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN OBSERVED EVIDENCE OF BLEEDING DURING THE BIOPSY. THE PHYSICIAN ATTEMPTED TO TREAT THE BLEED, AND AN RPD AND 1.6 NB3 PROBE WERE PLACED FOLLOWING THE BIOPSY. SUBSEQUENT MRI SCANS WERE OBTAINED, AND IMAGING CONFIRMED THE PRESENCE OF A BLEED/CLOT. THE PHYSICIAN ELECTED TO ABORT THE LITT PROCEDURE AND PROCEDURE AND PROCEEDED WITH A CRANIOTOMY TO TREAT THE BLEED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23348145 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REMASTER SAE FORM, IT WAS REPORTED THAT A PATIENT EXPERIENCED A FEVER OF UNSPECIFIED ORIGIN AND RAPID CHANGE IN MENTAL STATUS ON (B)(6) 2025 AFTER A LITT PROCEDURE ON (B)(6) 2025. THIS EVENT WAS DEEMED AS A SERIOUS REPORTABLE ADVERSE EVENT SINCE THE TREATING PHYSICIAN DETERMINED THE EVENT WAS POSSIBLY RELATED TO THE LITT PROCEDURE AND REQUIRED A NEW HOSPITALIZATION AND SURGICAL INTERVENTION. PATIENT WAS SENT TO AN OUTSIDE HOSPITAL WHERE BLOOD CULTURES WERE TAKEN (LATER GROWING SERRATIA). BRAIN MRI WAS OBTAINED; ABLATION CAVITY OVERALL LOOKS FAIRLY SIMILAR TO POSTOPERATIVE SCAN, THOUGH THERE ARE SMALL AMOUNTS OF DIFFUSION RESTRICTION OVERLYING THE FRONTAL LOBE. ON (B)(6) 2025, IT WAS OBSERVED THAT OVERALL, THE PATIENT'S MENTAL STATUS IMPROVED SINCE DIAGNOSIS WHILE ON ANTIBIOTICS; HOWEVER, MENTAL STATUS CONTINUES TO WAX AND WEAN. REPEAT BRAIN MRI WAS OBTAINED DEMONSTRATING CONCERN FOR PROGRESSIVE INTRACRANIAL INFECTION. THE PATIENT UNDERWENT A SURGICAL WASHOUT WITH CULTURES AND WAS PROVIDED MEDICATION INCLUDING STEROIDS.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 22977415 ↗
• MalfunctionJul 3, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT AT THE START OF THE ABLATION, THERE WAS NO HEATING OBSERVED ON THE SCREEN. INSIDE THE MRI ROOM, IT WAS NOTICED THAT THE PORTABLE CONNECTOR MODULE (PCM) CONNECTION TO THE LASER FIBER WAS THERMALLY FUSED. REPLACED THE PCM WITH A BACK UP PCM AND THE ABLATION PROCEDURE CONTINUED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398798 ↗
• MalfunctionJun 27, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT AFTER STARTING THE ABLATION AND PERFORMING MULTIPLE PULLBACKS, HEAT STOPPED REGISTERING ON THE SOFTWARE. LASER CONNECTIONS THROUGHOUT THE SYSTEM WAS INSPECTED, AND IT WAS FOUND THAT THE PORTABLE CONNECTOR MODULE (PCM) TO PROBE LASER CONNECTION WAS THERMALLY FUSED. THE LASER FIBER WAS REPLACED AND THE ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346904 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT FOLLOWING THE INITIAL 3-D VALUE METRIC PROBE VOID SCAN, A POSSIBLE BLEED NEAR THE SURFACE OF THE SKULL WAS NOTED ON THE LEFT SIDE. THE SURGEON PROCEEDED WITH THE ABLATION. FOLLOWING THE ABLATION, THE SURGEON TOOK A FLAIR SCAN AND A BLEED WAS CONFIRMED AND HAD PROGRESSED. THE SURGEON DECIDED TO FOLLOW LASER PROBE REMOVAL WITH AN OPEN CRANIOTOMY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22319658 ↗