RF 3000™ Radio Frequency Generator M001262200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729375463), received between Oct 15, 2019 and Dec 23, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED INSUFFICIENT ROLL OFF OCCURRED. THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION PROCEDURE ON THEIR KIDNEY. AN RF GENERATOR 3000 AND AN RF PROBE WERE USED. COMPUTED TOMOGRAPHY (CT) IMAGING AT THIS TIME SHOWED EVERYTHING APPEARED NORMAL. AT THE 3 MONTH FOLLOW UP APPOINTMENT IT WAS OBSERVED THAT THE TUMOR WAS NOT ABLATED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13075351 ↗
• MalfunctionDec 23, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED INSUFFICIENT ROLL OFF OCCURRED. THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION PROCEDURE ON THEIR KIDNEY. AN RF GENERATOR 3000 AND AN RF PROBE WERE USED. COMPUTED TOMOGRAPHY (CT) IMAGING AT THIS TIME SHOWED EVERYTHING APPEARED NORMAL. AT THE 3 MONTH FOLLOW UP APPOINTMENT IT WAS OBSERVED THAT THE TUMOR WAS NOT ABLATED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT ROLL-OFF, WHICH INDICATES THE CLINICAL ENDPOINT, WAS ACHIEVED AT THE TIME OF THE INDEX PROCEDURE. DURING THE INDEX PROCEDURE, A CT SCAN IS USED FOR PLACEMENT OF THE PROBE ONLY, THEY DO NOT PERFORM A CT WITH CONTRAST TO CONFIRM ABLATION. THE ABLATION IS CONFIRMED AT THE 3 MONTH FOLLOW UP USING A CT SCAN WITH CONTRAST, WHICH IN THIS CASE REVEALED THE TUMOR WAS NOT ABLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13075228 ↗
• MalfunctionDec 23, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED INSUFFICIENT ROLL OFF OCCURRED. THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION PROCEDURE ON THEIR KIDNEY. AN RF GENERATOR 3000 AND AN RF PROBE WERE USED. COMPUTED TOMOGRAPHY (CT) IMAGING AT THIS TIME SHOWED EVERYTHING APPEARED NORMAL. AT THE 3 MONTH FOLLOW UP APPOINTMENT IT WAS OBSERVED THAT THE TUMOR WAS NOT ABLATED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13075166 ↗
• MalfunctionMar 10, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED INSUFFICIENT ROLL-OFF OCCURRED. A RADIOFREQUENCY ABLATION PROCEDURE OF THE LIVER WAS BEING PERFORMED. A 5CM LEVEEN STANDARD ELECTRODE WAS USED WITH AN RF3000 GENERATOR TO ABLATE THE TISSUE. AFTER ABOUT 2 HOURS, ROLL-OFF WAS UNABLE TO BE ACHIEVED. THEREFORE, THEY FINISHED THE PROCEDURE WITHOUT THE DESIRED RESULT. ANOTHER PROBE WAS NOT ATTEMPTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9810974 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PAD BURNS OCCURRED. THE PATIENT WAS UNDERGOING RADIOFREQUENCY ABLATION (RFA) OF A FIBROTIC LIVER TUMOR. A LEVEEN STANDARD WAS USED WITH A RF3000 RADIO FREQUENCY GENERATOR. FOUR NON BSC GROUNDING PADS WERE POSITIONED ON THE PATIENTS THIGHS PER THE DFU. THE ABLATION WAS PERFORMED FOR 90 MINUTES IN THE FIRST TUMOR AND 60 MINUTES IN THE SECOND TUMOR. THE HIGHEST POWER WAS 200 WATTS. ROLL OFF WAS ACHIEVED. AT THE END OF THE PROCEDURE, WHILE REMOVING THE PADS, BURNS WERE OBSERVED ON BOTH LEGS UNDER ALL FOUR PADS. THE BURNS WERE SECOND AND THIRD DEGREE AND RANGED FROM 4X4CM TO 5X5CM. THERE WERE NO ISSUES WITH PAD CONTACT AND THE CONTACT AND SKIN CONDITIONS WERE REPORTED TO BE MONITORED DURING THE PROCEDURE. THE PATIENT WAS TREATED WITH TOPICAL CREAM AND ANTIBIOTICS. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: Burn(s)

  MAUDE report 9195102 ↗