LeVeen™ Standard M001262160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729454915), received between May 13, 2019 and Jul 6, 2026 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS INJURED, REQUIRING FURTHER INTERVENTION. A LEVEEN? STANDARD PROBE WAS SELECTED FOR USE IN AN ABLATION PROCEDURE. DURING THE PROCEDURE, ROLL-OFF WAS NEVER ACHIEVED, WHICH PROLONGED THE PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. ON (B)(6) 2026, 8 DAYS AFTER THE ABLATION PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH PAIN, FEVER, AND ELEVATED WHITE BLOOD CELL COUNT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED NEW RIGHT PLEURAL FLUID AND POSSIBLE LIVER ABSCESS. THE PATIENT WAS DIAGNOSED WITH SEPSIS AROUND THE DIAPHRAGM. THE PHYSICIAN BELIEVED THAT THE PROLONGED ABLATION RESULTED IN DAMAGE TO THE DIAPHRAGM. THE PATIENT WAS PUT ON ANTIBIOTICS TO TREAT THE SEPSIS. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND STABLE AT THE TIME OF REPORTING. THE PATIENT WAS SCHEDULED FOR REPEAT IMAGING, BUT IT HAD NOT YET BEEN PERFORMED.

  Patient problems: Abscess; Fever; High White Blood Cell Count; Pain; Pleural Effusion; Sepsis; Unspecified Tissue Injury

  MAUDE report 25728058 ↗
• MalfunctionAug 22, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED. IN (B)(6) 2024, THE PATIENT UNDERWENT A HEPATIC RADIO FREQUENCY ABLATION (RFA) PROCEDURE WITH AN RF3000 GENERATOR AND A 17G, 5CM X 15CM RF LEVEEN NEEDLE. THE LESION MEASURED ABOUT 25MM. ABLATION WAS PERFORMED WITH TWO HEAT-UP TIMES AT 200W FOR 15 MINUTES WITHOUT REACHING ROLL-OFF. NO PATIENT COMPLICATIONS WERE REPORTED. POST RFA PROCEDURE, IN (B)(6) 2024, MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED, WHICH CONCLUDED THAT THE TREATMENT HAD BEEN SUCCESSFUL EVEN THOUGH THE LESION HAD INCREASED IN SIZE AND NO POST-THERAPEUTIC SCARRING WAS VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026016 ↗
• MalfunctionMay 30, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED. A 5.0/13/15 LEVEEN STANDARD RF ELECTRODE WAS SELECTED FOR USE IN A PULMONARY RADIO FREQUENCY ABLATION PROCEDURE. THERE WAS DIFFICULTY DURING PLACEMENT, AND NO IMPEDANCE. PATCH WAS CHANGED TWO TIMES, BUT THIS DID NOT RESOLVE THE ISSUE. THE ELECTRODE WAS EXCHANGED, WHICH DID RESOLVE THE ISSUE. LESS THAN FIVE MINUTES OF TIME WAS WASTED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT ROLL OFF WAS ACHIEVED WITH A NEW ELECTRODE, AND THE PATIENT HAD A GOOD OUTCOME POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020686 ↗
• InjuryMay 13, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED INSUFFICIENT ROLL-OFF AND PAD BURNS OCCURRED. THE PATIENT HAD A 5CM TUMOR AT THE RIGHT UPPER RENAL POLE. EMBOLIZATION OF THE TUMOR-FEEDING VESSELS USING PARTICLES WAS PERFORMED ON THE PREVIOUS DAY. ON (B)(6) 2019, THE PATIENT WAS UNDERGOING A RADIO FREQUENCY ABLATION (RFA) OF THE RIGHT KIDNEY. THE POSITIONING OF THE PATIENT WAS LATERAL OBLIQUE LEFT, SO THE PATIENT WAS LYING ON HER SIDE. TWO GROUNDING PADS WERE PLACED ON THE BACKSIDE OF EACH THIGH (FOUR TOTAL). THE FIRST ABLATION WITH THE 5CM NEEDLE WENT EXACTLY ACCORDING TO ALGORITHM. AFTER 56 MINUTES, ROLL OFF WAS ACHIEVED AT 200 WATTS. THE 2ND ROLL OFF WAS ACHIEVED AFTER 9 MINUTES AT 200 WATTS. FOR THE SECOND ABLATION, THE NEEDLE WAS DRAWN BACK BY 3CM. AFTER A LONG TIME, ROLL-OFF WAS NOT ACHIEVED. AFTER 80 MINUTES, THE PROCEDURE HAD TO BE CANCELLED SINCE THE PATIENT DEVELOPED A FEVER OF 40 DEGREES CELSIUS. WHEN TURNING THE PATIENT AROUND, IT WAS NOTICED THE PATIENT HAD 2ND DEGREE PAD BURNS ALONG THE EDGES OF THE PADS. THE PATIENT DID NOT HAVE A URINARY CATHETER BUT ONLY WORE A DISPOSABLE DIAPER SO MOISTURE MAY HAVE GOTTEN UNDERNEATH THE ELECTRODES SINCE THE ELECTRODES WERE FIXED ON THE BACK OF THE THIGH. THE PHYSI

  Patient problems: Burn(s); Fever

  MAUDE report 8605381 ↗