Visualase 9735560 (UDI 00643169933385)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169933385), received between Dec 27, 2018 and May 30, 2019 — classified as 4 malfunctions.

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

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 23, 2018Terminated

   Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which can lead to the potential for low laser energy output from fiber or fiber burnout at lower wattage.

   Z-2501-2018 · Root cause: Equipment maintenance · FDA record ↗

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.

• MalfunctionMay 30, 2019Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, SALINE WOULD NOT PASS FROM THE DRIP CHAMBER INTO THE TUBING. A PICTURE WAS PROVIDED NOTING THAT THE CLIP WAS RELEASED AND IT WOULD NOT DRIP THROUGH WITH THE PUMP RUNNING OR AFTER IT WAS REMOVED. THE TUBING WAS REPLACED AND THE CASE PROCEEDED. THERE WAS A FIVE MINUTE DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8653886 ↗
• MalfunctionMay 1, 2019Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A LASER ABLATION PROCEDURE. IT WAS REPORTED THAT IN TRA-OPERATIVELY, IT WAS NOTED THE COOLING TUBING APPEARED TO HAVE TOO MUCH GLUE AND SALINE WOULD NOT FLOW. THE SITE SWAPPED TO ANOTHER DISPOSABLE THAT WAS AVAILABLE. THERE WAS NO IMPACT ON THE CASE AND THEY PROCEEDED AS NORMAL WITH LESS THAN FIVE MINUTES DELAY. THE EXTENSION TUBING WAS DISPOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8568994 ↗
• MalfunctionJan 4, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE CLEAR CAP ON THE LASER DIFFUSING FIBER (LDF) CONTINUED TO TURN INSTEAD OF STOPPING. THIS WAS NOT NOTICED DURING FIBER ASSEMBLY BY THE SCRUB AND WAS DISCOVERED BY THE SURGEON WHEN INSERTING THE FIBER INTO THE CATHETER. THE SURGEON WAS SATISFIED WITH THE ATTACHMENT BETWEEN THE FIBER AND CATHETER, BUT NOTICED THAT IT CONNECTED DIFFERENTLY THAN THE OTHER COOLING LASER APPLICATOR SYSTEM USED FOR THE OTHER TARGET. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219170 ↗
• MalfunctionDec 27, 2018Mechanical 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, THE SYSTEM HAD A DISPOSABLE FIBER WHICH DID NOT GET THE EXPECTED BEHAVIOR WHEN A 70% LASER TEST DOSE. THE SURGEON REQUESTED A NEW FIBER. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL FIBER USED. THIS WAS A TWO FIBER CASE. THE FIRST LASER FIBER WAS PLACED INTO THE SECOND LASER CATHETER AFTER THE SECOND FIBER DID NOT SEEM TO WORK AS EXPECTED. 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 8201456 ↗