Visualase 9735571 (UDI 00643169933415)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169933415), received between Oct 22, 2019 and Jul 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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" 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 22556422 ↗
• 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 10935885 ↗
• MalfunctionNov 14, 2019Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A SOFT NEURO TISSUE ABLATION PROCEDURE, THE BONE ANCHOR BOLT WAS DAMAGED WHEN BEING REMOVED FROM THE ANATOMY. IT WAS REPORTED THAT THE WINGS ON THE BOLT BROKE AWAY FROM THE STEM OF THE UNIT. IT WAS REPORTED THAT THE BOLT WAS REMOVED WITH A TOOL IN THE OPERATING ROOM (OR). ADDITIONALLY, THE PATIENT WAS BEING BROUGHT BACK TO THE OR TO WAKE UP AND EXUBATE AS PART OF THE PROCEDURE WORKFLOW WHEN THE REPORTED ISSUE OCCURRED. 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 Known Impact Or Consequence To Patient

  MAUDE report 9323503 ↗
• MalfunctionOct 22, 2019Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A SOFT NEURO TISSUE ABLATION, THE PLASTIC WINGS ON THE TITANIUM BONE ANCHOR DETACHED FROM THE METAL WHILE REMOVING THE BONE ANCHOR. IT WAS REPORTED THAT THE SITE WAS ABLE TO REMOVE THE REST OF THE BOLT WITH ANOTHER TOOL. 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 Known Impact Or Consequence To Patient

  MAUDE report 9217935 ↗