(Certified) ThermiRF+Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817771029181), received between Nov 19, 2023 and Nov 19, 2023 — classified as 1 injury.

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.

• InjuryNov 19, 2023No Apparent Adverse Event; No Apparent Adverse Event

  SPINESMITH REPRESENTATIVE REPORTED THAT THE ACCOUNT INFORMED THEM THAT THEIR RF+ THERMISMOOTH HANDPIECE IS HEATING UP TOO QUICKLY AND CAUSING (SPARKING AND ARCHING) WHEN IN CONTACT WITH THE PATIENT AND THEY ARE UNABLE TO DO PROCEDURES. SPINESMITH SENIOR CLINICAL SPECIALIST CONTACTED THE CUSTOMER FOR MORE INFORMATION. SPECIALIST REPORTED THAT AFTER SPEAKING WITH THE PRACTICE, SHE EXPLAINED THAT DURING THE PROCEDURE, THE PROBE TO SKIN CONTACT MAY BE DISRUPTED (FOR EXAMPLE IF DURING THE PROCEDURE THE PROBE WAS LIFTED FORM THE SKIN SURFACE OR IF THERE IS HAIR/DEBRIS IN THE WAY OF THE CONTACT SURFACE OF THE ELECTRODE), A SENSATION CAN OCCUR THAT FEELS LIKE PULLING/TIGHTENING ON THE SKIN OR A SHOCK. SPECIALIST DID REQUEST THE RETURN OF THE ELECTRODE USED FOR EVALUATION. CONTINUED CONVERSATION WITH OFFICE STAFF VERIFIED THAT WHILE PERFORMING THE PROCEDURE WITH THE THERMISMOOTH HANDPIECE, THERE WAS NO VISUAL "SPARKING" OR "ARCHING" OBSERVED RATHER THAT THE PATIENT DESCRIBED DISCOMFORT AS A "PULLING" OR "TIGHT" SENSATION WAS OCCURING. NO INJURIES WERE OBSERVED BY THE PHYSICIAN AND THEY HAVE SINCE HAD NO ISSUES. ELECTRODE WILL BE RETURNED FOR FINAL EVALUATION.

  Patient problems: Discomfort; Hyperresponsive to stimuli

  MAUDE report 18167239 ↗