Visualase 9735561 (UDI 00763000218195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000218195), received between Nov 22, 2019 and Sep 13, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE WITH THE DISPOSABLE KIT. IT WAS REPORTED THAT THERE WAS A TUBING PROBLEM; THE SALINE DID NOT FLOW OR DRIP FROM TUBE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460931 ↗
• MalfunctionSep 13, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE WITH THE DISPOSABLE KIT. IT WAS REPORTED THAT THE COOLING LINE HAD A LEAK AT THE LINE AND CONNECTOR. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460696 ↗
• MalfunctionNov 22, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A SEVEN TRAJECTORY SPINE ABLATION PROCEDURE, IT WAS NOTED THAT AFTER THE SECOND TRAJECTORY ABLATION WAS FINISHED, THE SALINE WAS SPRAYING FROM A SMALL HOLE OR BREACH IN THE SALINE TUBING JUST BELOW THE LEUR LOCK CONNECTION USED TO ATTACH THE TUBING TO THE COOLING CATHETER. IT WAS NOTED THAT IT WAS ON THE CLEAR/RETURN LINE SIDE. THE SURGEON REPLACED THE TUBING AND PROCEEDED WITH NO FURTHER LEAKS OR PROBLEMS. 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 Known Impact Or Consequence To Patient

  MAUDE report 9362891 ↗