Visualase 9735560 (UDI 00643169611993)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169611993), received between Mar 22, 2017 and Jan 5, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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.

• MalfunctionJan 5, 2018Mechanical Problem; Device Markings/Labelling Problem; Mechanical Problem; Device Markings/Labelling Problem

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A NEURO SOFT TISSUE ABLATION, THE COOLING CATHETER WAS MEASURING HALF A MILLIMETER OFF FROM THE EXPECTED VALUE. THE MEASUREMENT WAS CONFIRMED VIA A RULER. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7169111 ↗
• InjuryNov 10, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A LASER INDUCED THERMAL THERAPY (LITT), THE TIP OF THE CATHETER WAS MISSING WHEN THE SURGEON REMOVED THE CATHETER FROM THE PMT BOLT, A NON-MEDTRONIC PRODUCT, BONE ANCHOR. ON THE THERMAL MAP, IT WAS FOUND THAT THE HEAT MAP WENT FROM RED AT 50% POWER TO BLACK WITHIN SEVEN SECONDS. THE LASER WAS THEN TURNED OFF, FLUSHED WITH SALINE. THERE WAS NO INDICATION OF SALINE LEAKAGE INTO THE BRAIN. A T1 RUN ON THE PATIENT FOUND THAT THE TIP WAS AIR. A MEDTRONIC REPRESENTATIVE REPORTED THAT THE TIP WAS LEFT IN THE PATIENT AS THE SURGEON DID NOT WANT TO RESECT ADDITIONAL TISSUE TO REMOVE THE TIP. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF TEN MINUTES DUE TO THIS ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Iatrogenic Source

  MAUDE report 7018613 ↗
• MalfunctionMar 22, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  A MEDTRONIC ENGINEER, REPORTED ON BEHALF OF A MEDTRONINC TEST ENGINEER, THAT IDENTIFIED A THERMAL THERAPY COOLING CATHETER SYSTEM (CCS) LEAK AFTER 3 YEAR AGED TESTING. DURING EXECUTION OF A THERMAL THERAPY SYSTEM FLOW TEST PROTOCOL ON 3 YEAR ACCELERATED AGED CCS 400S, A LEAK WAS DETECTED IN ONE (OUT OF 7) OF THE PARTS. THIS WAS A 0.4MM CORE FIBER 10MM TIP. HOWEVER, THIS PART STILL PASSED THE FLOW RATE CRITERIA OF THIS TEST. THE LEAK WAS MINOR AND OCCURRED BETWEEN THE PROXIMAL END OF THE CATHETER TUBING AND THE HUB. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6425318 ↗