NeuroBlate® System 20360 (REF NB102)Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00816589020656), received between Dec 1, 2017 and Jan 6, 2021 — classified as 1 death, 33 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (31 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE THAT THE PATIENT EXPERIENCED INCREASED EDEMA AND SURGERY THAT NEEDED CRANIOTOMY SAME DAY OF THE PROCEDURE.

  Patient problems: Cerebral Edema

  MAUDE report 11123233 ↗
• InjuryApr 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT FOLLOWING THE ABLATION PROCEDURE, THE PATIENT EXPERIENCED WORSENED SENSORY LOSS IN THE LEFT FACE AND ARM. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10007303 ↗
• InjuryNov 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED DIABETES INSIPIDUS, SUPRAVENTRICULAR TACHYCARDIA AND ATRIAL FLUTTER WITH A 2:1 HEART BLOCK. THE PATIENT HAD A SERUM OSMOLALITY OF 320 AND URINE OSMOLALITY OF 120 WITH URINE SPECIFIC GRAVITY AT 1.06, AND WAS TREATED WITH AN INCREASE DOSAGE OF DEXAMETHASONE ON (B)(6) 2018 FOR THE DIABETES. THE PATIENT WAS ALSO TREATED WITH AN INCREASE IN MEDICATION AND ABLATION FOR THE HEART BLOCK. THE EVENTS WERE CONSIDERED DEFINITELY RELATED TO THE SURGICAL PROCEDURE. THE DIABETES WAS CONSIDERED RESOLVED AS OF (B)(6) 2018, AND THE OTHER EVENTS RESOLVED AS OF (B)(6) 2018. THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY ON (B)(6) 2018. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Patient Problem/Medical Problem; Tachycardia

  MAUDE report 9315484 ↗
• InjuryJul 31, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED SEVERE BRAIN DAMAGE AS A RESULT OF THE PROCEDURE WITH CORRESPONDING LOSS OF FUNCTION. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Brain Injury

  MAUDE report 8846476 ↗
• MalfunctionJan 10, 2019Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS WERE WITNESSED; THE TOP LEFT AND TOP RIGHT SHOWED COLD PIXELS BUT THERE WAS NOT ANY PIXEL DROP. IT WAS NOTED THAT THE PHYSICIAN PERFORMED A BIOPSY PRIOR TO THE ABLATION WITH AT LEAST 2 SPECIMENS TAKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235679 ↗
• InjuryDec 26, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, MULTIPLE PATIENTS "EXPERIENCES" NEUROLOGICAL DEFICITS (4 WORSENING PRE-MOTOR, 1 NEW UPPER EXTREMITY WEAKNESS, AND 1 HEMIPARESIS), 20 EXPERIENCED BLEEDING WHICH WERE TREATED CONSERVATIVELY, 1 EXPERIENCED A DEEP VEIN THROMBOSIS, AND 4 EXPERIENCED PERMANENT WEAKNESS WHICH DID NOT IMPROVE WITH FOLLOW-UP. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Neurological Deficit/Dysfunction; Thrombosis; Weakness

  MAUDE report 8196384 ↗
• InjuryDec 19, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED CEREBRAL EDEMA AND A HEMORRHAGE IN THE RIGHT CEREBELLUM. THE PATIENT ALSO EXPERIENCED INJURY TO THE RIGHT TEMPORAL BONE. THE PATIENT WAS TREATED WITH A CRANIOTOMY AND VENTRICULOSTOMY. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2017. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Edema; Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8182596 ↗
• MalfunctionDec 3, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, BLUE PIXELS WERE WITNESSED. THE BLUE PIXELS PREVENTED PROPER THERMAL DOSE THRESHOLD (TDT) LINE FORMATION. THE LASER WAS FIRING AT 128% POWER. THE LASER WAS THEN ROTATED AND POWER WAS REDUCED TO 100% WHICH APPEARED TO ALLEVIATE THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125828 ↗
• MalfunctionDec 3, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE USER WITNESSED BLUE PIXELS. IT WAS NOTED THAT THERE WAS A BIOPSY TAKEN PRIOR TO THE PROCEDURE. THERE WERE ALSO PIXELS IN THE VENTRICLE THAT WERE DISPLAYING THERMAL DOSE THRESHOLD (TDT) LINES. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125788 ↗
• MalfunctionDec 3, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE USER WITNESSED COLD PIXELS A SIGNIFICANT DISTANCE FROM THE PROBE. IT WAS NOTED THAT THE USER PERFORMED A BIOPSY PRIOR TO THE ABLATION PROCEDURE BUT IT WAS NOT FLUSHED WITH AN SOLUTION. IT WAS SUSPECTED THAT IT WAS DUE TO THE BIOPSY AND PROBE RETRACTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125746 ↗
• MalfunctionDec 3, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, WHILE ABLATING AT 100% FIRING POWER, BLUE PIXELS WERE NOTED. THE USER CAME OFF THE PEDAL AND THE BLUE PIXELS DISSIPATED. IT WAS NOTED THAT THE USER DID NOT LOWER THE FIRING POWER; THE USER STAYED ON 100% POWER AND THE BLUE PIXELS OCCURRED THROUGHOUT THE ENTIRE PROCEDURE. THE PHYSICIAN PERFORMED A BIOPSY PRIOR TO THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125709 ↗
• MalfunctionNov 15, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS WERE OBSERVED. IT WAS NOTED THE USER LOWERED THE LASER POWER AND PERFORMED A BIOPSY PRIOR TO THE ABLATION PROCEDURE. THE PHYSICIAN FLUSHED THE BIOPSY WITH A SOLUTION PRIOR TO THE ABLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073624 ↗
• MalfunctionOct 25, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS WERE WITNESSED APPROXIMATELY 15MM FROM THE PROBE. IT WAS NOTED THAT THE USER LET OFF THE FOOT PEDAL ONCE THE PIXELS WERE WITNESSED. THE PHYSICIAN PERFORMED A BIOPSY PRIOR TO THE ABLATION PROCEDURE BUT DID NOT FLUSH WITH A SOLUTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005235 ↗
• MalfunctionOct 25, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, BLUE PIXEL ARTIFACT WERE WITNESSED. THE USER WAS ABLATING USING FIRING POWER OF 128% AND THE USER NOTICED BLUE PIXELS ABOUT 1CM FROM THE PROBE. THE USER STOPPED DELIVERING LASER AND THE BLUE PIXELS SLOWLY DIMINISHED. THE USER WENT BACK ON AT 100% AND THE BLUE PIXELS CAME BACK. THE USER NOTED THE BLUE PIXEL ARTIFACT AND PROCEEDED THROUGH THE ENTIRE CASE WITH THE BLUE PIXEL ARTIFACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8005219 ↗
• MalfunctionOct 24, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE USER EXPERIENCED COLD PIXELS. THE LASER POWER WAS LOWERED. IT WAS NOTED THAT THE PHYSICIAN PERFORMED A BIOPSY PRIOR TO THE ABLATION PROCEDURE AND ALSO FLUSHED THE BIOPSY WITH A SOLUTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001544 ↗
• MalfunctionOct 24, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE USER EXPERIENCED COLD PIXELS. IT WAS NOTED THAT THE USER LEFT OFF THE FOOT PEDAL ONCE COLD PIXELS WERE WITNESSED. A BIOPSY WAS TAKEN PRIOR TO THE PROCEDURE (NO MANDREL WAS USED BEFORE PROBE PLACEMENT). THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001519 ↗
• InjuryOct 22, 2018No Apparent Adverse Event; No Apparent Adverse Event

  ACCORDING TO A LAANTERN AE UPDATE ON 11OCT2021, THE DESCRIPTION WAS UPDATED FROM JUST INTRACEREBRAL HEMORRHAGE (ICH) TO ICH, WORD FINDING DIFFICULTY AND RIGHT SIDE WEAKNESS, AND ADDITIONAL SERIOUSNESS CRITERION OF REQUIRING INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR BODY FUNCTION WAS INDICATED.

  Patient problems: Intracranial Hemorrhage; No Code Available

  MAUDE report 7992235 ↗
• MalfunctionOct 1, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS WERE WITNESSED. IT WAS NOTED THAT THE USER LEFT OFF THE FOOT PEDAL AND THAT THE PHYSICIAN PERFORMED A BIOPSY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922581 ↗
• MalfunctionOct 1, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, WHILE IN TREAT, AFTER THE 5TH PULL BACK OF THE PROBE, THE ORANGE HEAT MASK ON THE TOP LEFT CORNER OF THE PROBE'S EYE VIEW WAS NOT PRESENT. THE USER THEN RE-CREATED THE TRAJECTORY, CHANGED THE MASTER SCAN AND EVENTUALLY HAD TO RESTART THE SOFTWARE AND RELOAD THE PROFILE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT BUT IT WAS NOTED THAT IT CAUSED A 30 MINUTE DELAY TO THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922535 ↗
• MalfunctionSep 21, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, BLUE PIXELS APPEARED WHEN THE USER GOT CLOSE TO THE SKULL AND SULCI. THE USER LOWER THE POWER FROM 120% TO 100% AND THIS HELPED THE BLUE PIXELS DISSIPATE. THE USER ALSO LET OFF THE FOOT PEDAL ONCE THE BLUE PIXELS WERE WITNESSED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899500 ↗
• MalfunctionSep 21, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THERE WAS A BLUE PIXEL "BOWTIE" THAT WAS WITNESSED. THE USER LET OFF THE FOOT PEDAL DURING THE TREATMENT BUT THIS DID NOT HELP DISSIPATE THE BLUE PIXELS. IT WAS NOTED THERE WAS A BIOPSY PERFORMED THAT WAS A SINGLE CORE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899496 ↗
• MalfunctionSep 21, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS WERE WITNESSED. IT WAS NOTED THAT THE PHYSICIAN PERFORMED A BIOPSY PRIOR TO THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899417 ↗
• MalfunctionSep 21, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, BLUE PIXELS APPEARED WHEN FIRING AT 78%. ONCE THE ABLATION WAS STOPPED, THE BLUE PIXELS DISSIPATED. IT WAS NOTED THAT THE BLUE PIXELS APPEARED IN THE DIRECTION THAT THE USER WAS FIRING AND CAUSED THE USER TO STOP THE ABLATION BECAUSE HE COULD NOT SEE WHERE THE HEAT WAS SPREADING. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899416 ↗
• MalfunctionSep 17, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, DURING THE LAST ABLATION, AFTER REMOVING AND REPLACING THE PROBE THE LASER WAS NOT FULLY SEATED INTO THE CONNECTION OF THE PORTABLE CONNECTOR MODULE (PCM). THIS RESULTED IN THE FIBER CONNECTION AT THE PCM MELTING. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881757 ↗
• InjurySep 7, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED INTRACEREBELLAR HEMORRHAGE SYMPTOMS. THE PATIENT ALSO DEVELOPED A FUSIFORM ANEURYSM. THE PATIENT THEN HAD A CRANIECTOMY AND AN EXTERNAL VENTRICULAR DRAIN PLACED. THE PATIENT EXPERIENCED A HEMORRHAGE POST-CRANIECTOMY. THE PATIENT ALSO EXPERIENCED VASOSPASMS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Aneurysm; Hemorrhage, Cerebral; Patient Problem/Medical Problem

  MAUDE report 7856301 ↗