LeVeen™ Standard M001262050Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729300632), received between Aug 30, 2019 and Apr 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Retraction 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 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.

• MalfunctionApr 2, 2026Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE WAS DIFFICULT TO RETRACT FROM THE PATIENT. A LEVEEN? STANDARD RADIOFREQUENCY ABLATION (RF) PROBE WAS SELECTED FOR USE TO TREAT A CASE OF HEPATOCELLULAR CARCINOMA (HCC). THE DEVICE WAS EXTEND INTO THE PATIENT FOR TREATMENT. THE DEVICE WAS ABLE TO BE RETRACTED AND POSITIONED AT THIS TIME. THE ABLATION WAS COMPLETED, BUT WHEN REMOVAL OF THE PROBE WAS ATTEMPTED, THE DEVICE WAS STUCK. EVENTUALLY, THE PROBE WAS ABLE TO BE RETRACTED AND REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767739 ↗
• MalfunctionMar 30, 2026Retraction Problem

  IT WAS REPORTED THAT THE TINES OF THE NEEDLE WERE DIFFICULT TO RETRACT. A 3.0/15/15 PH LEVEEN STANDARD NEEDLE ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION PROCEDURE FOR A RENAL TUMOR. AFTER DEPLOYING THE DEVICE AND SUCCESSFULLY COMPLETING THE ABLATION, THE NEEDLES TINES COULD NOT BE RETRACTED. EXTRA TIME WAS REQUIRED TO ATTEMPT RETRACTION; EVENTUALLY, THE PROCESS SUCCEEDED AND THE DEVICE WAS REMOVED. ONCE OUTSIDE THE PATIENT, TISSUE WAS OBSERVED STUCK BETWEEN THE TINES, WHICH HAD PREVENTED PROPER RETRACTION. REMOVAL OF THE TISSUE ALLOWED THE TINES TO EXTEND AND RETRACT AS INTENDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24732175 ↗
• MalfunctionFeb 3, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED POST SEDATION. A RF3000 RADIOFREQUENCY GENERATOR AND A LEVEEN ELECTRODE NEEDLE WERE SELECTED FOR USE IN A LIVER TUMOR ABLATION PROCEDURE. THE NEEDLE WAS INSERTED INTO THE PATIENT AND REACHED THE SITE FOR ABLATION WHEN THE PHYSICIAN REQUESTED TO TURN ON THE GENERATOR TO START ABLATION. THE GENERATOR WAS SWITCHED ON, BUT POWER COULD NOT BE INCREASED. THE ACTIVE INDICATION BLUE LIGHT DID NOT TURN ON. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE PROCEDURE WAS CANCELLED AND WAS REFERRED FOR SURGERY SINCE THEY WERE UNABLE TO BE TREATED WITH RADIOFREQUENCY ABLATION. THE RADIOFREQUENCY GENERATOR WAS USED AFTER THIS EVENT SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446821 ↗
• MalfunctionAug 30, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THE TINES WERE DIFFICULT TO EXTEND. A RADIOFREQUENCY ABLATION (RFA) PROCEDURE WAS BEING PERFORMED. A LEVEEN STANDARD 3.0/15/15 ELECTRODE WAS SELECTED FOR USE. DURING PREPARATION, THE USER NOTICED THE DEPLOYMENT OF THE TINES WERE STIFF. THE DEVICE WAS NOT USED. ANOTHER LEVEEN STANDARD ELECTRODE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 8949232 ↗