Visualase 9735561 (UDI 00763000416447)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000416447), received between Jan 6, 2025 and Mar 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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.

• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT THE SITE FOUND A LEAK IN THE CATHETER AND HAD TO OPEN ANOTHER VISUALASE COOLING LASER APPLICATOR SYSTEM (VCLAS). PATIENT PRESENCE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584027 ↗
• MalfunctionFeb 4, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A PROSTATE LAZER ABLATION PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A DAMAGED TIP. THE PYRAMID-SHAPED PLASTIC TIP BROKE OFF. THE SITE WANTED TO EXPRESS THAT THE TIP DID NOT MELT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304667 ↗
• MalfunctionJan 6, 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 DISTAL TIP OF THE CATHETER FIBER BROKE OFF WHILE IN SURGERY. THERE WERE NO FOREIGN PIECES LEFT IN THE PATIENT. THE SURGEON DID NOT NOTE ANY MELTING, CHARRING, OR ABNORMAL HEATING. THE SURGEON OPENED ANOTHER FIBER TO CONTINUE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS LATER RECEIVED. IT WAS CLARIFIED THAT THE TIP OF THE COOLING CATHETER BROKE OFF. THE LASER FIBER TIP WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079237 ↗