LeVeen™ Standard M001262030Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729300618), received between Jun 18, 2019 and Mar 26, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Retraction Problem; Adverse Event Without Identified Device or Use Problem; Retraction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TINES OF THE NEEDLE WERE DIFFICULT TO RETRACT. THIS 3.5/15/15 PH LEVEEN STANDARD NEEDLE ELECTRODE WAS SELECTED FOR A RADIOFREQUENCY ABLATION PROCEDURE TO TREAT A LIVER TUMOR. AFTER SUCCESSFULLY DEPLOYING AND PERFORMING THE ABLATION USING THIS DEVICE, RESISTANCE WAS FELT WHEN ATTEMPTING TO RECAPTURE THE DEPLOYMENT TINES. DUE TO THE DIFFICULTY, IT WAS REMOVED WITH THE DEPLOYMENT TINES STILL EXTENDED. ONCE OUTSIDE THE BODY, IT APPEARED THAT THE TIPS OF THE DEPLOYMENT TINES WERE COVERED WITH WHAT SEEMED TO BE BURNED TISSUE, PREVENTING THEIR RECAPTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699401 ↗
• MalfunctionOct 25, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE FAILED TO DEPLOY. A 3.5/15/15 PH LEVEEN STANDARD WAS SELECTED FOR USE. THE NEEDLE FAILED TO DEPLOY. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668522 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NEEDLE CAUSED A BURN. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH LIVER CANCER. THE LEVEEN STANDARD WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS IN POSITION AND THE ABLATION WAS OCCURRING THE NEEDLE WAS HOT AND SMOKING WHICH RESULTED IN THE PATIENT BECOMING BURNED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER THE PROCEDURE, THE PATIENT WAS CONSIDERED STABLE.

  Patient problems: Burn(s)

  MAUDE report 11015566 ↗
• InjuryNov 25, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED A HEMATOMA OCCURRED. A RADIOFREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED. ON RENAL TUMOR. A 3.5CM LEVEEN STANDARD ELECTRODE WAS USED WITH AN RF3000 GENERATOR TO ABLATE THE TISSUE. WHEN THE ELECTRODE WAS DEPLOYED, THE TINES WERE BUNCHED UP AND NOT PROPERLY EXTENDED. THIS OCCURRED SEVERAL TIMES, SO THE ELECTRODE WAS REMOVED AND TESTED OUTSIDE THE PATIENT. THE ELECTRODE SEEMED TO WORK FINE. A NEW ELECTRODE WAS THEN SELECTED AND USED TO COMPLETE THE ABLATION. THIS LED TO A PROLONGED PROCEDURE TIME. DURING THE PROCEDURE AT AN UNKNOWN TIME, THE PATIENT COMPLAINED OF PAIN. A SCAN WAS PERFORMED WHICH NOTED THE PATIENT HAD COMPLICATION OF BLEED WITH SUBCAPSULAR HEMATOMA. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND TWO ADDITIONAL CT SCANS WERE PERFORMED. MEDICATION WAS ADMINISTERED TO REDUCE THE BLEEDING. THE BLEEDING STOPPED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Hematoma

  MAUDE report 10906214 ↗
• MalfunctionAug 13, 2019Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING RETRACTED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A HEPATIC TUMOR. ABLATION WAS PERFORMED WITH THIS LEVEEN STANDARD. THE PHYSICIAN HAD A DIFFICULT TIME ATTEMPTING TO CLOSE THE ARRAY AFTER THE ABLATION. AFTER MULTIPLE ATTEMPTS AT CLOSING THE ARRAY AND APPLYING A LARGE AMOUNT OF STRENGTH THE PHYSICIAN WAS ABLE TO RETRACT THE ARRAY AND REMOVE FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889517 ↗
• MalfunctionJul 1, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING DEPLOYED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A HEPATIC CARCINOMA TUMOR. THE LEVEEN STANDARD WAS BEING USED FOR THIS PROCEDURE. AFTER THE FIRST ABLATION WITH THE DEVICE, THE PHYSICIAN RETRACTED THE TINES IN ORDER TO ADVANCE IT A BIT IN THE TUMOR. HOWEVER, HE WAS THEN NOT ABLE TO EXTEND THE TINES AGAIN. THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751526 ↗
• MalfunctionJul 1, 2019Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING EXTRACTED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A HEPATIC CARCINOMA TUMOR FOR A PATIENT. THE LEVEEN STANDARD WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS IN POSITION THE PHYSICIAN PERFORMED THE ABLATION OF THE TUMOR. AFTER THE ABLATION THE PHYSICIAN HAD DIFFICULTY TO CLOSE THE DEVICE. EVENTUALLY THE PHYSICIAN WAS ABLE TO CLOSE THE DEVICE AFTER USING A VERY STRONG FORCE WITH TWO HANDS. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750924 ↗
• MalfunctionJun 18, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE PHYSICIAN WASN'T ABLE TO DEPLOY THE DEVICE INSIDE THE RENAL TUMOR. A RADIOFREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A CYSTIC RENAL CELL CARCINOMA TUMOR AND A 3.5CM LEVEEN NEEDLE ELECTRODE WAS INTENDED TO BE USED IN THE PROCEDURE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE INSIDE THE RENAL TUMOR, IT WAS UNABLE TO DEPLOY. THE PHYSICIAN ATTEMPTED A 4CM LEVEEN NEEDLE ELECTRODE, BUT THIS DEVICE DID NOT DEPLOY EITHER. THE PROCEDURE WAS STOPPED AND NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707213 ↗