Visualase 9735561 (UDI 00643169933378)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169933378), received between Aug 31, 2020 and Aug 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Heating” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2020Insufficient Heating; Insufficient Heating

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE TESTING WITH THE THERMAL THERAPY SYSTEM, THERE WAS AN ISSUE WITH THE DISPOSABLE COOLING CATHETER SYSTEM (CCS) KIT. IT WAS REPORTED THAT LESIONS FORMED NON-UNIFORMLY AND ABLATED TISSUE WAS ONE SIDED AS THE UNIT ABLATED IN A 180 DEGREE REGION INSTEAD OF 360 DEGREES AROUND THE LASER DIFFUSING FIBER (LDF). IT WAS REPORTED THAT TISSUE TESTING WAS BEING CONDUCTED WHERE UNDER SMALLER ABLATION TIMES, THE ABLATED TISSUE WAS ON ONE SIDE OF THE LDF AND CATHETER. IT WAS NOTED THAT SWITCHING LDF'S DID NOT RESTORE FUNCTIONALITY, LEADING TO THE COOLING CATHETER BEING SUSPECTED TO BE THE CAUSE OF THE ISSUE. IT WAS NOTED THAT A 15W LASER WITH 8ML/MIN FLOW AND 16 SECONDS OF EXPOSURE TIME WERE BEING USED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 10471849 ↗