ThermiRF+Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817771029044), received between Feb 1, 2024 and Feb 14, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  ON 16JAN2024, CUSTOMER SUPPORT WAS NOTIFIED BY A SALES REPRESENTATIVE OF AN ADVERSE EVENT. CHETCO MEDICAL (ACCT #: (B)(4)) REPORTED A PATIENT THEY PERFORMED A THERMIVA TREATMENT HAD BURNS INSIDE HER VAGINA. THE THERMIVA TREATMENT WAS PERFORMED IN (B)(6) 2023. THE PATIENT REPORTED SHE FELT DISCOMFORT AFTER THE TREATMENT AND VISITED HER OBGYN IN (B)(6) 2023. THE PATIENT'S OBGYN INFORMED HER SHE HAD BURNS INSIDE HER VAGINA. THE CUSTOMER MENTIONED THEY WERE PERFORMING AGGRESSIVE TREATMENT DUE TO THE PATIENT'S URINARY INCONTINENCE. THE PATIENT ONLY HAD ONE THERMIVA TREATMENT IN (B)(6) WHEN IN (B)(6) HER OBGYN NOTIFIED HER OF THE BURN. THE CUSTOMER REPORTED IN (B)(6) THEY ARE PERFORMING PRP TREATMENTS FOR THE BURN ON THE PATIENT. THE CUSTOMER HAS NOT REPORTED ANY OTHER ISSUES WITH THE THERMIRF+ GENERATOR (SN #: (B)(6)). THE UNIT WAS REQUESTED FOR EVALUATION TO ENSURE IT IS FUNCTIONING AS NORMAL.

  Patient problems: Burning Sensation

  MAUDE report 18707983 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT NOTICED A BURN ON RIGHT THIGH WHERE GROUNDING PAD WAS PLACED DURING HER THERMIVA TREATMENT WHEN SHE ARRIVED HOME. OFFICE STAFF REPORTED THAT DURING THE TREATMENT PATIENT MENTIONED THAT THERE WAS A SENSATION OF HEAT WHERE THE GROUNDING PAD WAS PLACED, SO THE NURSE RE-APPLIED THE GROUNDING AND THE PATIENT REPORTED THAT THEY FELT FINE SO THE TREATMENT PROCEEDED.

  Patient problems: Burning Sensation; Discomfort

  MAUDE report 18627617 ↗