Visualase 9735559 (UDI 00763000218171)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000218171), received between Jul 24, 2019 and Nov 9, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2021Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PROCEDURE WAS A NEURO ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778041 ↗
• MalfunctionOct 28, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT THE CATHETER WAS TOO TIGHT ON THE STIFFENING STYLET. THE DOCTOR TRIED TO GET THE STIFFENING STYLET DOWN THE CATHETER AND WAS UNABLE TO GET IT TO WORK. IT WAS NOT POSSIBLE AND THE SURGEON HAD TO PULL A NEW ONE AND CONTINUED ON. THE PROCEDURE WAS COMPLETED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712875 ↗
• MalfunctionSep 24, 2021Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS A 10 MINUTE DELAY IN THE CASE. A SMALL ABLATION AT THE TIP OF THE FIRST PULLED BACK CATHETER. CLOSE TO THE INTERNAL CAPSULA. NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12525268 ↗
• MalfunctionAug 3, 2021Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THERE WAS AN ISSUE WITH THE CATHETER HAVING A CHARRED TIP AFTER THE SECOND TRAJECTORY. THERE WAS ARTIFACT DURING THE SECOND TRAJECTORY. THE SURGEON INCREASED IRRIGATION AND TURNED OFF ABLATION. THE REPRESENTATIVE REPLACED THE CATHETER BUT THE LASER WAS USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS  COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF FIVE MINUTES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267589 ↗
• MalfunctionJul 2, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THERE WAS A PIN HOLE LEAK IN THE SALINE TUBING. THE TUBING WAS REPLACED CAUSING A FIVE MINUTE DELAY. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108782 ↗
• MalfunctionFeb 23, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT THE CATHETER FOR THE THERAPY SYSTEM HAD VISUAL EVIDENCE OF CHARRING WHEN REMOVING THE CATHETER FROM THE ANATOMY. IT WAS REPORTED A SECOND CATHETER WAS USED WITH RECURRENCE OF THE REPORTED ISSUE. IT WAS NOTED THAT SALINE FLOW THROUGH THE COOLING CATHETER SYSTEM (CCS) WAS SUFFICIENT WITH NO MALFUNCTIONS OF THE PUMP. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364960 ↗
• MalfunctionDec 2, 2020Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 10935887 ↗
• MalfunctionJul 1, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE PROCEDURE WAS DELAYED LESS THAN FIVE MINUTES. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A HAMARTOMA HYPOTHALAMIC ABLATION. IT WAS NOTED THAT THE ISSUE WAS SUSPECTED TO BE A MANUFACTURING DEFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10218672 ↗
• MalfunctionNov 25, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, WHEN CONNECTING THE SALINE TUBING TO THE CATHETER, THE SURGEON NOTICED THAT ONE OF THE CONNECTORS ON THE TUBING LOOKED DISCOLORED/CLOUDY AND WAS CONCERNED THAT THE TUBING WOULD LEAK. THE SITE DID NOT TEST IF THE TUBING WOULD LEAK AFTER RUNNING THE INITIAL SCANS. THE PROCEDURE WAS COMPLETE USING A DIFFERENT FIBER KIT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY DUE TO THE TUBING ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9372084 ↗
• MalfunctionJul 24, 2019Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT WHILE CONDUCTING PRECLINICAL DATA COLLECTION, IT WAS NOT POSSIBLE TO GET SALINE THROUGH THE TUBING. IT WAS FOUND THAT THE ISSUE WAS WITH THE PORTION THAT CONNECTED TO THE IV BAG. ANOTHER PUMP TUBING SET WAS OPENED AND THEY WERE ABLE TO GET SALINE FLOW. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8821570 ↗