Visualase 9735559 (UDI 00643169933361)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169933361), received between Apr 29, 2019 and Jun 17, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT POST-OPERATIVELY, THE FIBER LUER-LOCK CONNECTOR DID NOT LOCK WELL. IT WAS REPLACED WITH A NEW FIBER AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND NO REPORTED SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704301 ↗
• MalfunctionMay 22, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A LASER ABLATION PROCEDURE. IT WAS REPORTED THAT IN TRA-OPERATIVELY, THE TUBING WAS UNBOXED AND HAD NO CLAMP ON THE TUBING. A MANUFACTURER REPRESENTATIVE NOTICED THIS ISSUE AND THE PROCEDURE PROCEEDED NORMALLY. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS THIRTY-SECOND SEAT FOR THE REPRESENTATIVE TO TAKE A PICTURE OF THE TUBING. THE TUBING WAS NOT AVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8632696 ↗
• MalfunctionApr 29, 2019Mechanical Problem; Infusion or Flow Problem; Mechanical 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, THE EXTENSION TUBING SET WAS NOT PASSING SALINE AND IT APPEARED THAT THE TUBE WAS SEALED. THERE WAS TEN-MINUTE DELAY TO THE PROCEDURE TO OPEN A NEW COOLING LASER APPLICATOR SYSTEM. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8562662 ↗