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Visualase 9735571 (UDI 00763000255954)Recalls & reported problems

Medtronic Navigation, Inc. · ACCESSORY KIT 9735571 VISUALASE NEURO · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000255954), received between May 10, 2021 and May 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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

Device problems

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 10, 2021Material Fragmentation; Material Fragmentation

    ADDITIONAL INFORMATION RECEIVED STATING THAT THE TYPE OF PROCEDURE BEING COMPLETED WAS A NEURO PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11796925 ↗

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Sources and updates

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