RF 3000™ Radio Frequency Generator M00126220H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729404262), received between Mar 11, 2020 and Mar 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionMar 11, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ROLL OFF. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT. THE LEVEEN NEEDLE WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS DEPLOYED AFTER PUNCTURE, IT WAS REPORTED THAT IT WAS UNABLE TO ACHIEVE SUFFICIENT ROLL OFF. THERE WERE NO OTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9818084 ↗