star RF Electrode 18-07s10FRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08809306760067), received between Dec 29, 2025 and Dec 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Temperature 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 29, 2025Temperature Problem; Temperature Problem

  THIS FOLLOW-UP REPORT IS SUBMITTED TO PROVIDE THE RESULTS OF THE MANUFACTURER'S COMPLETED EVALUATION OF THE RETURNED DEVICE. AS PREVIOUSLY REPORTED, A SUPERFICIAL SKIN BURN WAS OBSERVED DURING A THYROID RADIOFREQUENCY ABLATION PROCEDURE ON (B)(6) 2025. THE AFFECTED AREA WAS TREATED WITH TOPICAL OINTMENT AND COVERED WITH A BANDAGE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE SUSPECT DEVICE WAS RETURNED TO THE MANUFACTURER AND EVALUATED. BASED ON THE COMPLETED INSPECTION, TESTING, AND ANALYSIS, NO EVIDENCE OF A DEVICE MALFUNCTION OR PERFORMANCE ABNORMALITY WAS IDENTIFIED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23919295 ↗