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Visualase 9735570Recalls & reported problems

Medtronic Navigation, Inc. · ACCESSORY KIT 9735570 VISUALASE BODY · Class 1

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 00643169933408), received between Apr 16, 2019 and Apr 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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

  • Mechanical Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionApr 16, 2019Mechanical Problem; Mechanical Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NON-NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE COOLING CATHETER "ACCORDIONED" WHEN THE STIFFENING STYLET WAS ADVANCED THROUGH THE CATHETER DAMAGING THE CATHETER. THE SITE HAD TO OPEN A NEW SET TO COMPLETE THE CASE. 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 8519919 ↗

Other Cannula and trocar, suprapubic, non-disposable devices

All Cannula and trocar, suprapubic, non-disposable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.