Visualase 9735571 (UDI 00763000416461)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000416461), received between May 11, 2022 and May 7, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) STRUGGLED TO REMOVE THE BONE ANCHOR. THE BONE ANCHOR SNAPPED. THE HCP HAD TO MAKE A SMALL INCISION TO USE AN INSTRUMENT IN ORDER FOR THE BONE ANCHOR TO BE REMOVED. THE SITE STATED THAT AFTER THE PROCEDURE, THE TITANIUM BONE ANCHOR WAS INTENDED TO BE UNSCREWED AND REMOVED EASILY BUT THE WHITE PLASTIC PART WAS SNAPPED DURING REMOVAL. THE HCP HAD TO MAKE A SMALL INCISION AND USED ADDITIONAL INSTRUMENT TO REMOVE THE TITANIUM BONE ANCHOR. THE DEVICE CAME OUT INTACT AS INSPECTED BY THE HCP. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116856 ↗
• MalfunctionOct 30, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT THE TITANIUM BONE ANCHOR HAD A CRACK IN IT. THE SITE OPENED THE KIT IN THE STERILE FIELD AND NOTICED THE CRACK BEFORE USE. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427239 ↗
• MalfunctionAug 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE ANCHOR BOLT IN THE ACCESSORIES KIT, INSPECTED PRIOR TO SCRUB OPENING THE STERILE PACKAGING, AND THE WHITE PLASTIC PORTION OF THE BOLT WAS CRACKED. A BACKUP PRODUCT WAS USED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22888852 ↗
• MalfunctionJul 1, 2025Mechanical Problem; Device Damaged Prior to Use; Mechanical Problem; Device Damaged Prior to Use

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A LASER INTERSTITIAL THERMAL THERAPY PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OUT OF BOX ISSUE WITH AN INSTRUMENT. DURING A CASE AND REMOVING INSTRUMENTS FROM THE PACKAGING, THE INSTRUMENT HAD A CRACK. THE SITE OPENED UP ANOTHER INSTRUMENT AND PROCEEDED WITH CASE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CRACK IN THE BONE ANCHOR WAS NOTICE DURING CASE SETUP AND HAD NO PATIENT INTERACTION. IT WAS THE WHITE PART OF BONE ANCHOR, BETWEEN THE WINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371073 ↗
• MalfunctionJun 19, 2025Mechanical Problem; Mechanical Problem

  THIS ISSUE WAS REPORTED TO HAVE OCCURRED OUT-OF-BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293305 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GENERALIZED CONVULSIVE SEIZURE. IT HAPPENED WHEN THE PATIENTS WAS ALREADY AT HOME 8 DAYS AFTER THE PROCEDURE. THE PATIENT PRESENTED CONVULSIVE SEIZURES AND HAD BEEN HOSPITALIZED FOR 1 WEEK. THEY RECEIVED CORTICOTHERAPY IV 100MG FROM (B)(6) 2024. THE FOLLOWING EXAMS HAD BEEN PERFORMED: TDM ON (B)(6) 2024, EEG ON (B)(6) 2024, IRM ON (B)(6) 2024, RX ON (B)(6) 2024, TDM THORAX ON (B)(6) 2024, TDM ON (B)(6) 2024. THEY WERE RELEASED FROM THE HOSPITAL WITHOUT CONSEQUENCES.

  Patient problems: Convulsion/Seizure

  MAUDE report 21410425 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GENERALIZED CONVULSIVE SEIZURE. IT HAPPENED WHEN THE PATIENTS WAS ALREADY AT HOME 8 DAYS AFTER THE PROCEDURE. THE PATIENT PRESENTED CONVULSIVE SEIZURES AND HAD BEEN HOSPITALIZED FOR 1 WEEK. THEY RECEIVED CORTICOTHERAPY IV 100MG FROM (B)(6). THE FOLLOWING EXAMS HAD BEEN PERFORMED: TDM ON (B)(6), EEG ON (B)(6), IRM ON (B)(6), RX ON (B)(6), TDM THORAX ON (B)(6), TDM ON (B)(6). THEY WERE RELEASED FROM THE HOSPITAL WITHOUT CONSEQUENCES.

  Patient problems: Convulsion/Seizure

  MAUDE report 21410316 ↗
• MalfunctionDec 12, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT WHEN THE A BONE ANCHOR (TITANIUM) WAS OPENED, THE SURGEON NOTICED IT FELT TIGHTER THAN USUAL AROUND THE ALIGNMENT ROD. ADDITIONALLY, WHEN MOVING THE ANCHOR ON THE ROD, THE BONE ANCHOR WAS SCRATCHING THE ROD AND MAKING AUDIBLE TONES. AFTER A NEW NEURO ACCESSORY KIT WAS OPENED, THERE WERE NO ISSUES PRESENT. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917577 ↗
• MalfunctionNov 27, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE METAL PART AND THE PLASTIC CAP OF THE CATHETER STYLET FROM THE ACCESSORY KIT DETACHED WHEN EXCHANGING THE STYLET WITH THE LASER FIBER. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211050 ↗
• MalfunctionNov 20, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING THE LAST STEP OF THE PROCEDURE, WHICH WAS TAKING OUT THE BONE ANCHOR, IT BROKE. THE HEALTH CARE PROFESSIONAL COULD NOT UNSCREW THE ANCHOR FROM THE TOP, SO THEY NEEDED TO USE A SPECIAL TOOL TO HOLD IT FROM THE METAL PORTION CLOSE TO THE SKIN IN ORDER TO UNSCREW IT. THERE WAS NO DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170427 ↗
• MalfunctionNov 15, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT  THE PLASTIC PART OF THE BONE ANCHOR BROKE AT BOTH BONE ANCHORS. AFTER THE PROCEDURE WHEN TRYING TO REMOVE THE BONE ANCHORS FROM THE SKULL THE PLASTIC PART OF THE BONE ANCHOR DETACHED FROM THE TITANIUM PART. THE TITANIUM PART HAD TO BE REMOVED WITH THE HELP OF PLIERS. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THE BONE ANCHORS WERE FIXED WITH THE SPECIFIC SCREW DRIVER. POSSIBLY THE FIXATION WAS TOO STRONG. THE BONE ANCHOR COULD BE REMOVED WITH THE HELP OF 3RD PARTY TOOLS. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142268 ↗
• MalfunctionNov 15, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT  THE PLASTIC PART OF THE BONE ANCHOR BROKE AT BOTH BONE ANCHORS. AFTER THE PROCEDURE WHEN TRYING TO REMOVE THE BONE ANCHORS FROM THE SKULL THE PLASTIC PART OF THE BONE ANCHOR DETACHED FROM THE TITANIUM PART. THE TITANIUM PART HAD TO BE REMOVED WITH THE HELP OF PLIERS. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THE BONE ANCHORS WERE FIXED WITH THE SPECIFIC SCREW DRIVER. POSSIBLY THE FIXATION WAS TOO STRONG. THE BONE ANCHOR COULD BE REMOVED WITH THE HELP OF 3RD PARTY TOOLS. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141684 ↗
• InjuryJun 30, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED INTRAOPERATIVELY. IT WAS REPORTED THAT THERE WAS A SUBDURAL HAEMATOMA NOTICED ON MRI SCANS AT CORTICAL ENTRY AFTER THE PATIENT WAS TAKEN TO THE RADIOLOGY DEPARTMENT IMMEDIATELY POST-INSERTION OF THE SKULL POST AND LASER FIBRE. THE PATIENT RETURNED TO THE OPERATING THEATRE WITHOUT PERFORMING LASER ABLATION, THE SKULL POST AND LASER FIBRE WERE REMOVED, AND A CRANIOTOMY AND DRAINAGE OF SUBDURAL HEMATOMA PERFORMED. ONE OF THE ATTENDING SURGEONS SPOKE TO THE MEDTRONIC REPRESENTATIVE (REP) ABOUT THE SKULL POST. THE DOCTOR WAS QUESTIONING HOW SHARP THE THREAD WAS. HE SAID THAT DURING THE PROCEDURE, THE POST HAD FELT "LOOSE" WHEN THEY HAD REMOVED IT. HE ALSO WAS QUESTIONING THE SHARPNESS OF THE END OF THE DRILL BIT. THE PATIENT REMAINED HOSPITALIZED WITH APPROXIMATELY 50% VISUAL IMPAIRMENT FROM THE SUBDURAL HEMATOMA ACQUIRED DURING THE PROCEDURE. THERE WAS A DELAY OF UNKNOWN TIME.

  Patient problems: Hematoma; Unspecified Tissue Injury; Visual Impairment

  MAUDE report 17236803 ↗
• MalfunctionMay 30, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A SOFT TISSUE NEURO ABLATION PROCEDURE. IT WAS REPORTED THAT THE STYLET WAS ABLE TO BE INSERTED INTO THE CATHETER BUT COULD NOT BE REMOVED. THE SITE OPENED A NEW 3MM FIBER KIT AND STIFFENING STYLET, AND THE ISSUE WAS RESOLVED. THERE WAS LESS THAN A FIVE MINUTE SURGICAL DELAY DUE TO THE REPORTED ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021905 ↗
• MalfunctionMar 8, 2023Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE BONE ANCHOR BROKE WHEN IT WAS SCREWED INTO THE SKULL. DURING THE IMPLANTATION OF THE TITANIUM BONE ANCHOR, THE TITANIUM PART OF THE BONE ANCHOR DETACHED FROM THE WHITE PLASTIC PART WITH A SLIGHT ROTATION FORCE APPLIED. THE BONE ANCHOR WAS NOT FULLY INSERTED, THEREFORE, A HIGH FORCE WAS UNLIKELY TO HAVE CAUSED THE DETACHMENT. THE BONE ANCHOR WAS NOT FULLY INSERTED INTO THE BONE, AND THEREFORE THE TITANIUM THREAD COULD BE REMOVED FROM THE BONE WITH A CLAMP. THE BONE ANCHOR WAS REMOVED FROM THE PATIENT. IT BROKE BEFORE IT HAD REACHED ITS FINAL POSITION. A NEW ACCESSORY KIT SET WAS OPENED AND THE NEW BONE ANCHOR WAS USED AND FIT WELL. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505466 ↗
• MalfunctionNov 17, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE OPENED THE SEALED BAG FOR THE ACCESSORY KIT, THEY FOUND THE BONE ANCHOR TO BE CRACKED ON THE PLASTIC PART. THE SITE HAD ANOTHER KIT THEY USED INSTEAD. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818479 ↗
• MalfunctionSep 14, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT THERE WERE PROBLEMS WITH THE STYLET NOT SITTING IN THE CATHETER DURING SET UP. THEY PROCEEDED BY OPENING ANOTHER STYLET. THE LEUER-LOCK WAS DEFECTIVE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419775 ↗
• MalfunctionSep 12, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT ONE OF THE BONE ANCHORS HAD A CRACK IN THE WHITE PLASTIC WHEN IT WAS OPENED. THE SITE OPENED A NEW ACCESSORIES KIT TO CONTINUE WITH THE CASE. THE ISSUE WAS DISCOVERED PRE-OPERATIVELY. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402118 ↗
• MalfunctionMay 11, 2022Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT THE BONE ANCHOR SCREW WAS DAMAGED WHILE ATTEMPTING TO REMOVE THE UNIT POST-OPERATIVE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14354905 ↗