NA RF-DGP-IZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067049650), received between Apr 15, 2026 and Apr 15, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Grounding Malfunction” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Grounding Malfunction

  IT WAS REPORTED THAT THE DURING THE PROCEDURE ONCE THE PROBE REACHED APPROXIMATELY 74 DEGREES THE GENERATOR WOULD GIVE THE MESSAGE ¿GROUNDING PAD NOT SECURE¿. ADJUSTMENTS WERE MADE WITHOUT RESOLUTION AS WELL AS A SECOND GROUNDING PAD ATTEMPTED, BUT THE ISSUE WOULD NOT RESOLVE. AS A RESULT, THE CASE WAS ABORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885707 ↗
• InjuryApr 15, 2026Grounding Malfunction

  IT WAS REPORTED THAT THE DURING THE PROCEDURE ONCE THE PROBE REACHED APPROXIMATELY 74 DEGREES THE GENERATOR WOULD GIVE THE MESSAGE "GROUNDING PAD NOT SECURE". ADJUSTMENTS WERE MADE WITHOUT RESOLUTION AS WELL AS A SECOND GROUNDING PAD ATTEMPTED, BUT THE ISSUE WOULD NOT RESOLVE. AS A RESULT, THE CASE WAS ABORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885702 ↗