Visualase 9735542 (UDI 00763000313364)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000313364), received between Jun 26, 2020 and Apr 5, 2023 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Insufficient Heating; Insufficient Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LASER GENERATOR FAILED THE 15W TEST. ALL OTHER POWER LEVELS PASSED TESTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683830 ↗
• MalfunctionMar 30, 2023Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT IT WAS NOTICED VIA THE HEAT MAP, THAT SALINE WAS NOT FLOWING AROUND THE CATHETER. THEY WERE FIRING AT 70% FOR A MINUTE PRIOR TO RECOGNIZING AND TURNING SALINE ON. THEY WERE ABLE TO CONTINUE AND FINISH THE CASE WITH NO ISSUES. THE TIP WAS NOT CHARRED FOLLOWING THE CASE, AND THERE WAS NO MELTING. THE SUSPECTED CAUSE WAS THAT NO SALINE AT THE BEGINNING CAUSED MINOR WARPING OF THE CATHETER. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16646186 ↗
• MalfunctionAug 15, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT THERE WAS BLOOD IN THE CATHETER. THE SITE STATED THAT THERE WAS BLOOD IN ONE OF THE CATHETERS INDICATING A LEAK. THIS WAS AFTER THE HEALTH CARE PROFESSIONAL ABLATED ON HIGH FOR A LONG PERIOD OF TIME. THE HCP WAS NOT SURPRISED WITH THIS RESULT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225142 ↗
• MalfunctionJul 25, 2022Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS A FTP LOGIN FAILURE. THE MANUFACTURER REPRESENTATIVE (REP) STATED THAT DURING A CASE, THEY HAD RECEIVED A CONNECTION FTP LOGIN FAILURE. THE REP HAD TO CLEAR THE LOCKS ON THE COMPUTER BECAUSE "SESSION MANAGER BUSY", GOT FTP LOGIN FAILURE. THEY HAD TO REBOOT THE ENTIRE WORKSTATION. THEY TRIED TO LOGIN AGAIN AND WAS ABLE TO GET TO NEXT SCREEN BUT WAS THEN KICKED BACK TO THE LOGIN SCREEN. THE REP WAS THEN ABLE TO LOGIN BUT HAD TO CLEAR LOCKS AGAIN TO OPEN THE SESSION. THERE WAS NO DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15096749 ↗
• MalfunctionApr 12, 2022Mechanical Problem; No Device Output; Mechanical Problem; No Device Output

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT TWO LASER FIBERS WERE DAMAGED DURING THE PROCEDURE. IT WAS REPORTED THAT THE TIP ON THE FIRST FIBER HAD BEEN REMOVED FROM THE UNIT. THE SECOND FIBER WAS NOTED TO HAVE A CHARRED TIP. WHEN RUNNING TEST DOSAGES, IT WAS REPORTED THAT NO HEAT DISPLAYED ON THE TEMPERATURE MAP (TMAP) AT 30% AND 50% OUTPUT. 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 14083710 ↗
• MalfunctionMar 17, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE CATHETER CHARRED. THE MANUFACTURER REPRESENTATIVE (REP) STATED THAT AFTER A CASE WHEN THEY WERE REMOVING THE LASERS WHERE 3 WERE PLACED, IT WAS NOTICED THAT ONE OF THE LASERS WERE CHARRED. THERE REP BELIEVES THIS WAS THE 3RD LASER THAT WAS ABLATED. THERE WAS NO REPORTED DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13790776 ↗
• MalfunctionMar 11, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USE DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT A PORTION OF THE COOLING CATHETER DISCONNECTED FROM THE UNIT WHEN REMOVING IT FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS A CUT IN THE UNIT. ADDITIONALLY, THERE WAS NO NOTED DAMAGE TO THE LASER FIBER, NO SALINE LEAKAGE AND NO ISSUES WITH THE ABLATION. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13739528 ↗
• MalfunctionAug 17, 2021No Device Output; No Device Output

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SYSTEM HAD BEEN USED WITH NO MONITOR ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331663 ↗
• MalfunctionJul 20, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE DRILL GUIDE SEIZED UP, THE COOLING LASER APPLICATOR SYSTEM HAD A SALINE LEAK BUT THE TIP WAS INTACT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197441 ↗
• MalfunctionJun 25, 2021Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE PUMP STOPPED FUNCTIONING AT THE END OF THE CASE. THEY WERE ABLE TO COMPLETE WHAT THEY INTENDED TO DO IN THE CASE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065905 ↗
• InjuryJun 2, 2021Adverse 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 FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT HAD A LARGE VISUAL FIELD DEFICIT. NO UPDATE HAS BEEN PROVIDED PERTAINING TO THE PATIENT'S CONDITION.

  Patient problems: Visual Impairment

  MAUDE report 11923653 ↗
• MalfunctionApr 30, 2021Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THEY NOTICED THE SALINE WAS NOT FLOWING PROPERLY. THEY NOTICED THAT THE PUMP WAS FLOWING ABNORMALLY WHEN IN THE FORWARD POSITION. THEY SWAPPED TUBING AND SETUP THE TUBING TO FLOW USING THE REVERSE OPTION ON THE PUMP. THE PROCEDURE WAS COMPLETED USING THE SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE. AFTER THE CASE, THE MANUFACTURER REPRESENTATIVE WAS TESTING THE PUMP AND NOTICED IT WAS MAKING ABNORMAL NOISES THAT IT USUALLY DOES NOT MAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752884 ↗
• MalfunctionMar 26, 2021No Device Output; Use of Device Problem; No Device Output; Use of Device Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SURGEON DID NOT MEASURE THE INACCURACY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574527 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM THAT WAS USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT POST-OPERATIVELY, IT WAS NOTED THAT THE PATIENT HAD A LEFT SUPERIOR HOMONYMOUS/INCONGRUOUS VISUAL DEFECT. THE SPONSOR ASSESSED THE EVENT AS UNKNOWN RELATIONSHIP TO THERMAL THERAPY SYSTEM. AN UPDATE WAS PROVIDED THAT IT WAS UNKNOWN IF THE EVENT WAS RELATED TO THE PROCEDURE, ANESTHESIA, OR EPILEPTIC DISEASE SATE. IT WAS NOTED THAT THE SEVERITY OF THE EVENT WAS MILD. IT WAS REPORTED THAT THE EVENT WAS UNRESOLVED WITH NO FURTHER ACTION PLANNED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO ACTIONS WERE TAKEN. THE CAUSE AND IMPACT TO THE PATIENT WAS UNKNOWN. IT WAS REPORTED THAT THE EVENT WAS UNRESOLVED WITH NO FURTHER ACTIONS.

  Patient problems: Visual Impairment

  MAUDE report 11528039 ↗
• MalfunctionJun 26, 2020No Device Output; No Device Output

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT AFTER A CASE, A MANUFACTURER REPRESENTATIVE WENT TO COLLECT THE LASER LOGS BUT THERE WAS NO DATA LISTED. ADDITIONALLY, THERE WAS A MESSAGE REPORTING MISSING DATA FOR THE MOVIES AS WELL. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 10199844 ↗