Visualase 9735559 (UDI 00763000416423)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000416423), received between Feb 9, 2023 and Aug 8, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (14 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.

• MalfunctionAug 8, 2025Leak/Splash; Temperature Problem; Leak/Splash; Temperature Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THEY OBSERVED THAT THE CATHETER WAS DAMAGED ON THE INSIDE. THE CATHETER WAS NOT FUNCTIONING AS EXPECTED¿THE TEMPERATURE WAS NOT INCREASING APPROPRIATELY. UPON INSPECTION, THEY NOTICED FLUID LEAKING FROM THE CATHETER. THEY EXAMINED THE FIBER OPTIC AND CONFIRMED THAT THE RED CONTROL LIGHT WAS ON, WHICH RULED OUT A FIBER BREAKAGE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748403 ↗
• MalfunctionJul 21, 2025Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. WHILE WALKING THROUGH A DEMONSTRATION, IT WAS NOTICED THAT THERE WAS A SALINE LEAK/DRIP AT THE BLUE STRAIN RELIEF SHEATH WHILE IN THE MAGNETIC RESONANCE IMAGING (MRI) MACHINE. TOWELS WERE USED TO CONTAIN THE DRIPPAGE AND CLEAN IT UP WITH NO APPARENT DAMAGE CAUSED. AFTER THE DRY RUN, IT WAS NOTICED THAT THE LOCAL REPRESENTATIVE (REP) COULD JUST PULL THE OUTER CANULA OF THE INNER CANULA/LUMEN AS IF THE ADHESION SPOT INSIDE THE BLUE STRAIN RELIEF WAS NOT HOLDING. THE REP HAD ALSO NOTICED WHEN THEY SET UP THAT THE STIFFENING STYLET WAS SLIGHTLY DIFFICULT TO INSERT, BUT IT DID PASS WITH SOME FRICTION. IT WAS NOTED THAT THE ACCESSORY KIT WAS "WAY WAY" PAST EXPIRATION DATE. IT HAD EXPIRED ON 2020-OCT-25. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556378 ↗
• MalfunctionJun 6, 2025Thermal Decomposition of Device; Mechanical Problem; Biocompatibility; Thermal Decomposition of Device; Mechanical Problem; Biocompatibility

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT AFTER RUNNING THE FIRST POST-ABLATION SCAN, NOTICED THERE WAS SOME SALINE POOLED AROUND CATHETER #1. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, THE SURGEON AND SURGERY CONSULTANT EXAMINED IT AND RAN A SYRINGE OF SALINE THROUGH IT TO SEE IF THEY COULD IDENTIFY THE LEAK. THEY OBSERVED A SMALL LEAK AROUND 3CM BACK FROM THE DISTAL TIP THAT CORRESPONDED TO A BIT OF DISCOLORATION (POSSIBLY CHAR) ON THE CATHETER. NOTHING WAS OBSERVED IN THE LIVE ABLATION SESSION ON THE TMAPS OR DMAPS THAT WOULD HAVE INDICATED A LEAK, BUT AFTER REVIEWING THE TMAP IMAGES IN THE REVIEW TOOL, IT LOOKED LIKE THE LEAK OCCURRED RIGHT AT THE END OF THE FINAL ABLATION FOR CATHETER #1. 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 22158813 ↗
• MalfunctionMar 7, 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 A SALINE LEAK WAS FOUND AT THE END OF SURGERY IN THE HEAD COIL OF THE CATHETER. THE ISSUE WAS IDENTIFIED POST-OPERATIVELY. THE SALINE TUBING WAS DISCARDED FOLLOWING THE DISCOVERY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. IT WAS LATER REPORTED THAT THE ISSUE WAS NOT A PRODUCT DEFECT ISSUE. THE IRRIGATION TUBING WAS DISCONNECTED AND LEFT IN THE MAGNETIC RESONANCE IMAGING (MRI) HEAD COIL WITHOUT BEING PINCHED OFF AT THE INGRESS OF THE SALINE BAG. IT WAS MORE SO USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547060 ↗
• MalfunctionMar 7, 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 THERE WAS A SALINE TUBING LEAK. THE SITE RAN 2 DIFFERENT SALINE TUBING'S. 2 LASERS WERE PUT TOGETHER IN SERIES AND THEN THE OTHER 4 IN SERIES. WHEN THEY PROCEEDED TO RUN ABLATION ON THE FIRST 2, NO ISSUES. WHEN SWITCHING TUBING TO BEGIN THE 4 LASERS, SALINE TUBING CONNECTION LEAKED. THE SITE NOTICED THE LEAK AT THE JUNCTION OF WHERE TUBING'S CONNECT WITH ONE ANOTHER. THEY 'STRETCHED' TUBING MULTIPLE TIMES AND WAS ABLE TO RESOLVE LEAK AFTER A FEW TRIES. THE PROCEDURE CONTINUED WITH NO DELAY OR IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546851 ↗
• MalfunctionJun 21, 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 THE SALINE TUBE CONNECTING TO THE CATHETER WAS LEAKING AT THE CONNECTION SIDE WHILE CONNECTED TO THE PATIENT. THE MANUFACTURER REPRESENTATIVE (REP) CHANGED OUT THE TUBING AND RESUMED ABLATION. THE PATIENT WAS NOT HARMED. THE TUBING LEAKED OUTSIDE OF THE PATIENT'S HEAD. THE CASE WAS DELAYED BY ABOUT TEN MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580899 ↗
• MalfunctionApr 2, 2024Break; Mechanical Problem; Break; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS A TUBING LEAK. THERE WAS A LEAK ON THE OUTSIDE PORTION OF THE TUBING CLOSER TO THE CONSOLE. THE LEAK WAS NOT CLOSE TO THE CATHETER. THEY REPLACED THE CONSOLE SIDE OF THE TUBING AND THEY WERE ABLE TO PROCEED WITH THE CASE. THE SITE HAD 4 EXTRA TUBING SETS AND OPENED ONE OF THOSE. 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 19019704 ↗
• MalfunctionJan 5, 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  THERE WAS A CATHETER LEAK. DURING THE ABLATION THERE WAS A SALINE TUBING LEAK. THE SITE STATED THAT THE SALINE TUBE LEAKED AT THE JUNCTION OF WHERE THE BOTH CONNECT. THE TUBING WAS FROM 3MM FIBERS. 4 LASERS WERE CHAINED TOGETHER (ALL 3MM FIBERS), AND THEY ALL LEAKED. THE SITE SWAPPED OUT THE PORTION THAT WAS LEAKING (THE ONE THAT GOES THROUGH THE PUMP) AND DISCONNECTED 1 LASER SINCE THE SITE WAS FINISHED. THE SITE THEN HAD 3 CHAINED TOGETHER, AND THEY WERE STILL LEAKING. THEY FINISHED BURNING THE 2ND FIBER. THEN DISCONNECTED IT FROM THE SERIES TO LEAVE ONLY 2 REMAINDER LASERS. THEY SWAPPED IT OUT FOR THE TUBING THAT WAS EXTRA FROM PRIOR CASES (FROM 10MM FIBER) AND THERE WAS NO LEAK. THERE WAS A DELAY OF ABOUT 5 MINUTES. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE CATHETER WAS NOT LEAKING, IT WAS THE SALINE TUBING WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454736 ↗
• MalfunctionJan 5, 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  THERE WAS A CATHETER LEAK. DURING THE ABLATION THERE WAS A SALINE TUBING LEAK. THE SITE STATED THAT THE SALINE TUBE LEAKED AT THE JUNCTION OF WHERE THE BOTH CONNECT. THE TUBING WAS FROM 3MM FIBERS. 4 LASERS WERE CHAINED TOGETHER (ALL 3MM FIBERS), AND THEY ALL LEAKED. THE SITE SWAPPED OUT THE PORTION THAT WAS LEAKING (THE ONE THAT GOES THROUGH THE PUMP) AND DISCONNECTED 1 LASER SINCE THE SITE WAS FINISHED. THE SITE THEN HAD 3 CHAINED TOGETHER, AND THEY WERE STILL LEAKING. THEY FINISHED BURNING THE 2ND FIBER. THEN DISCONNECTED IT FROM THE SERIES TO LEAVE ONLY 2 REMAINDER LASERS. THEY SWAPPED IT OUT FOR THE TUBING THAT WAS EXTRA FROM PRIOR CASES (FROM 10MM FIBER) AND THERE WAS NO LEAK. THERE WAS A DELAY OF ABOUT 5 MINUTES. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE CATHETER WAS NOT LEAKING, IT WAS THE SALINE TUBING WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454701 ↗
• MalfunctionDec 18, 2023Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346696 ↗
• MalfunctionDec 18, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT DURING A 3 LASER CASE (ALL 3MM FIBERS), THE SITE USED 2 SALINE TUBINGS: 1 TUBING HAD 2 LASERS (PH <(>&<)> O) CHAINED TOGETHER, THE SECOND JUST HAD THE SINGLE TUBING (A). BOTH SALINE TUBINGS LEAKED AT THE JUNCTION WHERE THE 2 PARTS CONNECTED. CATHETER PH HAD CHARRING WHEN REMOVED, LOCATED AT THE 10MM MARK. CATHETER O HAD WHITE RESIDUE ADHERED NEAR THE 10MM MARK WHEN REMOVED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. PATIENT IMPACT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346691 ↗
• MalfunctionDec 18, 2023Thermal Decomposition of Device; Mechanical Problem; Thermal Decomposition of Device; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346672 ↗
• InjuryDec 12, 2023Thermal Decomposition of Device; Mechanical Problem; Thermal Decomposition of Device; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT DURING THE END OF A PROCEDURE, THERE WAS AN AREA OF THE BRAIN THAT THE SURGEON FLAGGED AS ABNORMAL IN APPEARANCE. THE CATHETER WAS REMOVED, AND IT WAS DISCOVERED THAT THERE WAS A LEAK IN THE CATHETER ALONG WITH SOME CHARRING. THERE WAS SOME BRAIN TISSUE STUCK TO THE CATHETER AT THE SITE OF THE LEAK. ADDITIONAL BRAIN SCANS WERE ACQUIRED, AND THE SURGEON REPORTED THAT THE ABNORMALITY THEY NOTED WAS LIKELY DUE TO A BLEED IN THE AREA WHERE THE CATHETER WAS FOUND TO BE LEAKING. THE SURGEON REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT AND NO CHANGE IN THE PATIENT'S CARE PLAN. IT WAS NOTED THAT AN ADDITIONAL KIT WAS NOT OPENED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 18311643 ↗
• 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 17021893 ↗
• MalfunctionFeb 9, 2023Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT AT THE END OF THE WHOLE SESSION OF ABLATION THE SITE REALIZED THERE WAS A SMALL SALINE LEAK IN THE CONNECTION BETWEEN THE 8M SALINE LINE AND THE 4M SALINE LINE. THE SITE NOTICED WHEN DISCONNECTING THE LINES. THEY HAD SALINE RETURN DURING THE WHOLE SESSION AND COULD SEE THE HEATING WAS COOLING DOWN WHEN THEY TURNED OFF THE LASER. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16338018 ↗