VISUALASE 9735542 (UDI 00763000521370)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000521370), received between Feb 13, 2025 and Feb 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K211269); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S COOLING FLUID PUMP MALFUNCTIONED IN A CASE. THE PROCEDURE WAS APPROXIMATELY 80% COMPLETE, AT WHICH TIME THE PUMP STOPPED MOVING AND BEGAN MAKING A "SQUEALING" NOISE AS IF A GEAR WAS JAMMED INSIDE. THE MANUFACTURER REPRESENTATIVE (REP) TRIED REVERSING DIRECTIONS AS WELL AS DIFFERENT POWER OUTLETS, BUT THE ISSUE PERSISTED. THE REP WAS ABLE TO MANUALLY MOVE A BEARING IN THE PUMP AND GET IT WORKING AGAIN FOR APPROXIMATELY 30 SECONDS, BUT THEN IT STOPPED MOVING AGAIN. THE REP WAS UNABLE TO GET IT WORKING AT THAT POINT. THE SURGEON THEN OPTED TO ABANDON FURTHER USE OF THE SYSTEM. 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 24316272 ↗
• MalfunctionFeb 13, 2025Infusion 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 WHEN INSTALLING THE SYSTEM, THE WATER PUMP DID NOT WORK. IT HAD POWER, BUT WHEN THE LEVER WAS PULLED DOWN, NOTHING HAPPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377223 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211269. One submission often covers many models, so check the product and lot details in each record.

• Z-0244-2023 · Oct 14, 2022 · Open, Classified
  Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical