ArvatiRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817771029068), received between Nov 19, 2023 and Apr 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, DR. (B)(6) PLASTIC SURGERY (CUSTOMER ID: (B)(6)) REPORTED TO AN AREA SALE MANAGER THEY WERE EXPERIENCING ISSUES WITH BURNING WHEN PERFORMING THERMITIGHT PROCEDURE. THE PROVIDER WHO PERFORMED THE PROCEDURES IS NO LONGER AT THEIR PRACTICE. THERE WERE FOUR PATIENTS THAT WERE BURNED. OF THE FOUR PATIENTS, TWO HAVE PERMANENT SCARRING. PER THE CUSTOMER, ONE THEY HAVE BEEN TREATING FOR YEARS FREE OF CHARGE. THE TWO MOST SEVER CASES ARE FROM A SINGLE THERMITIGHT PROCEDURE TO THE NECK AND THIGH AREA. THESE BURNED OCCURRED ON THEIR ARVATI GENERATOR (SN: (B)(6). IN (B)(6) 2023 THE CUSTOMER SENT IN THEIR GENERATOR FOR REPAIR DUE TO A FAULT 150. A FAULT 150 IS A BATTERY ISSUE, AND THE UNIT WILL NOT FUNCTION. ALL THE BURNS HAPPENED PRIOR TO RETURNING THE GENERATOR TO OUR LOCATION FOR REPAIR. AT THE TIME OF THE FAULT 150, AND RETURN OF THE GENERATOR, THERE WAS NO MENTION OF THE ADVERSE EVENTS OR BURNS. A LOANER CERTIFIED THERMI RF+ (SN #: (B)(6) WAS SENT ON 03FEB2023. THE CUSTOMER ARVATI GENERATOR (SN #: (B)(6) WAS UNABLE TO BE EVALUATED DUE TO THE FAUL AND THE CUSTOMER DECIDED TO KEEP THE LOANER CERTIFIED THERMIRF+ GENERATOR (SN #: (B)(6). AT THIS TIME, THIS IS ALL THE INFORMATIO

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 19087545 ↗
• InjuryNov 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PHYSICIAN REPORTED TO SALES REPRESENTATIVE ON (B)(6) 2021 THAT DURING THE THERMISMOOTH PROCEDURE THE PATIENT COMPLAINED OF A SPARKING AND BURNING SENSATION. PHYSICAN REPORTED THAT HE HAD PICTURES BUT THEY WERE NEVER OBTAINED DURING THE INITIAL CALL BACK ON (B)(6) 2021. PHYSICIAN DID REPORT THAT DURING SETUP HE HAD TO PUSH THE ELECTRODE INTO THE GENERATOR VERY HARD. PHYSICIAN REQUESTED THAT THE GENERATOR AND ELECTRODE BE EVALUATED. FOLLOW UP CALL ON (B)(6) 2021 BY THEN QUALITY MANAGER FOR SPINESMITH, COLLECTED THAT THERE WAS A MAXIMUM SKIN TEMP OF 45.5C FROM THE FLIR CAMERA, THE TREATMENT LASTED 10 MINUTES, PHYSICIAN REPORTED NO PROBLEMS DURING THE TREATMENT. CUSTOMER ACCOUNT NOTES THAT A 2ND TREATMENT WAS PERFORMED THE PATIENT OVER A BIGGER AREA (CROW'S FEET AND CHEEKBONES), PATIENT COMPLAINED AT 2ND TREATMENT AS WELL. ON (B)(6) 2023 ARVATI SN# (B)(6) AND ELECTRODES RFE-10-D-G2 SN# (B)(6) AND RFE-15-D-G2 SN# (B)(6) WERE SENT IN FOR INVESTIGATION. INSPECTION AND TESTING OF CUSTOMER OWNED GENERATOR SHOWED THAT ACTIVE RF PERFORMED FOR 1HR WITH SET TEMPERATURE OF 90C, IMPEDANCE LEVELS, TEMPERATURE RESPONSE AND SAFETY TESTING ALL TESTINGED WITHIN EXPECTED PARAMETERS. THERE WERE NOT ANOM

  Patient problems: Burn(s)

  MAUDE report 18167259 ↗
• InjuryNov 19, 2023Manufacturing, Packaging or Shipping Problem; Patient Device Interaction Problem; Manufacturing, Packaging or Shipping Problem; Patient Device Interaction Problem

  PHYSICIAN REPORTED THAT HER LAST TWO PATIENTS REPORTED MULTIPLE SHOCK SENSATION DURING THEIR THERMIVA TREATMENTS. INVESTIGATION NOTED THAT THE PHYSICIAN WAS USING RFDE-VA-G2 LOT# L18E027 AND GROUNDING PAD CAT: #2130ACLOT# 20160720 EXPIRED AS OF 07/19/2018. AS A COURTESY, THE PHYSICIAN WAS SENT REPLACEMENT ELECTRODES AND GROUNDING PADS AND INFORMED THAT USE OF EXPIRED GROUNDING PADS IS NOT ACCEPTABLE. COMPLAINT WAS CLOSED 07/27/21. DURING 2023 FDA AUDIT, INSPECTOR INDICATED THAT THE COMPLAINT REQUIRED RE-ASSESSMENT. COMPLAINT WAS RE-OPENED ON 08/04/23. ATTEMPTS HAVE BEEN MADE ON 08/08/23 (VOICEMAIL LEFT), 08/18/23 (EMAIL) AND 08/22/23 (EMAIL). NO RESPONSE AS OF 11/19/23. REVIEW OF THE CUSTOMER WEBSITE NOTES THAT THE OFFICE IS STILL PROVIDING THERMIVA PROCEDURES. ADDITIONAL FOLLOW UP EMAIL REQUESTING STATUS OT THERMIVA PROCEDURE SENT TO PHYSICIAN ON 11/16/23 BY CURRENT SPINESMITH QUALITY MANAGER.

  Patient problems: Electric Shock

  MAUDE report 18167243 ↗