LeVeen™ SuperSlim™ M001262260Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729441694), received between Jan 30, 2018 and Sep 23, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (11 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Twisted/Bent; Activation Problem

  It was reported that resistance occurred when pushing the needle and the sub-needle was bent.A 2.0/17/15 LeVeen SuperSlim was selected for use in a hepatic artery chemotherapy embolization procedure in the liver. During preparation, resistance was encountered when pushing the needle. After opening the needle, one of the sub-needles was bent. The procedure was completed with another of the same device. There were no patient complications as a result of this event and the patient status was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867714 ↗
• MalfunctionSep 2, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569606 ↗
• MalfunctionJun 8, 2026Power Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL-OFF OCCURRED. A 2.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR AN ABLATION PROCEDURE IN THE LIVER. AFTER THE NEEDLE LEAD WAS PUNCTURED TO THE DESIGNATED POSITION, THE ABLATION WAS STARTED. THE CONSOLE IMMEDIATELY STOPPED WORKING, AND THE RESISTANCE VALUE DIRECTLY REACHED THE MAXIMUM VALUE AND COULD NOT BE ABLATED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435619 ↗
• MalfunctionApr 1, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS DEFORMED. A LEVEEN? SUPERSLIM? WAS SELECTED FOR USE IN A LIVER ABLATION PROCEDURE. DURING DEVICE PREPARATION, WHEN THE PACKAGING WAS OPENED, IT WAS DISCOVERED THAT THE NEEDLE WAS DEFORMED. ANOTHER NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757296 ↗
• MalfunctionFeb 12, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL-OFF OCCURRED. A 2.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION OF THE LUNG. THE NEEDLE WAS PLACED PROPERLY IN THE TARGET LESION; HOWEVER, THE NEEDLE SOMETIMES SHOWED INTERMITTENT HEATING, AND AT OTHER TIMES IT DID NOT HEAT UP AT ALL. THE IMPEDANCE COULD NOT INCREASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME NEEDLE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324287 ↗
• MalfunctionJan 9, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS BENT. A 2.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE IN THE LIVER. DURING PREPARATION, THE NEEDLE WAS FOUND BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019377 ↗
• MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE BENT. A 2.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR USE IN A RENAL RADIO ABLATION PROCEDURE. THE NEEDLE BENT DURING INSERTION INTO THE PATIENT. THE NEEDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE. 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 23769360 ↗
• MalfunctionOct 29, 2025Failure to Unfold or Unwrap; Adverse Event Without Identified Device or Use Problem; Activation Problem; Failure to Unfold or Unwrap; Adverse Event Without Identified Device or Use Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE ELECTRODE FAILED TO DEPLOY PROPERLY. A 2.0CM X 15CM LEVEEN? SUPERSLIM? NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE IN THE LEFT LIVER. DURING THE PROCEDURE, THE NEEDLE ELECTRODE FAILED TO DEPLOY PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23419246 ↗
• MalfunctionSep 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS BENT. A 2.0CM X 15CM LEVEEN? SUPERSLIM? NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE TO TREAT LIVER CANCER. DURING THE PROCEDURE INSIDE THE PATIENT, IT WAS NOTED THAT THE NEEDLE WAS BENT, RESULTING IN FREQUENT SHUTDOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110688 ↗
• MalfunctionApr 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS BENT. A 2.0CM X 15CM LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE OF A LIVER TUMOR. WHEN PREPARING FOR THE PROCEDURE OUTSIDE THE PATIENT, IT WAS FOUND THAT THE NEEDLE WAS A LITTLE BENT NEAR THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918392 ↗
• MalfunctionFeb 18, 2025Failure to Unfold or Unwrap; Material Twisted/Bent; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS BENT. UPON OPENING THE PACKAGE OF THIS 2.0/17/15 LEVEEN SUPERSLIM NEEDLE ELECTRODE, THE NEEDLE SECTION WAS BENT, AND IT WAS STUCK WHEN THE NEEDLE CAME OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394439 ↗
• MalfunctionJul 22, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE ARRAY DID NOT DEPLOY PROPERLY. A 2.0CM X 15CM LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE. DURING THE PROCEDURE, A NEEDLE DEPLOYMENT FAILURE OCCURRED. WHEN ATTEMPTING TO DEPLOY THE NEEDLE AFTER THE PUNCTURE, IT DID NOT OPEN NORMALLY. THE NEEDLE WAS REMOVED. THE NEEDLE SIZE WAS CHANGED TO A 3.0CM X 15CM, AND ABLATION WAS PERFORMED AS USUAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798290 ↗
• MalfunctionDec 15, 2023Device Displays Incorrect Message; Material Twisted/Bent; Device Displays Incorrect Message; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE KINKED. A 2.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR USE TO TREAT LIVER CANCER. DURING THE PROCEDURE, THE DEVICE FREQUENTLY REPORTED AN ALERT AND STOPPED WORKING. IT WAS FOUND THAT THE NEEDLE WAS KINKED AFTER IT WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335272 ↗
• MalfunctionNov 30, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE WAS NOT FULLY DEPLOYED. A 2.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR RADIOFREQUENCY ABLATION OF THE LIVER. DURING THE PROCEDURE, THE DAUGHTER NEEDLE WAS NOT FULLY DEPLOYED AND COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886969 ↗
• MalfunctionAug 9, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE WAS DIFFICULT TO EXTEND. A LEVEEN NEEDLE ELECTRODE 2.0/17/15 WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE, TO TREAT THE LIVER. DURING THE PROCEDURE, A NEEDLE WAS INSERTED AND ATTEMPTED TO DEPLOY CLOSE TO THE LESION. HOWEVER, THE HANDLE WAS TOO TIGHT TO BE USED, EVEN THOUGH IT WAS TRIED AGAIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS IN STABLE CONDITION AND NO COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195391 ↗
• MalfunctionMar 31, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A BENT NEEDLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 2.0X17X15 LEVEEN SUPERSLIM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE IMPEDANCE RISE OF THE RADIO FREQUENCY (RF) MACHINE WAS COMPLETED AND AN ABNORMAL NEEDLE WAS FOUND AFTER THE NEEDLE WAS PULLED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13969397 ↗
• MalfunctionOct 17, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE TINES WERE DIFFICULT TO DEPLOY. A LEVEEN NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE OF THE LIVER. WHEN THE NEEDLE WAS INSERTER INTO THE LESION, THE TINES DID NOT FULLY EXPAND. A DIFFERENT DEVICE, SAME MODEL, WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THE PATIENT WAS STABLE AFTER TREATMENT WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12644474 ↗
• MalfunctionSep 20, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A LEVEEN NEEDLE ELECTRODE AND RF3000 RADIOFREQUENCY GENERATOR WERE SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE. THE DEVICE WAS CONNECTED TO THE MAIN UNIT, HOWEVER IT DID NOT FUNCTION. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495821 ↗
• MalfunctionJul 1, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT ARRAY EXPANSION WAS POOR. A LEVEEN SUPERSLIP NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE TO TREAT LIVER CANCER. DURING DEPLOYMENT WITH THE NEEDLE PARTLY OPENED, IT WAS NOTED THAT ARRAY EXPANSION WAS POOR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100301 ↗
• MalfunctionFeb 3, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT TIP DAMAGE OCCURRED. DURING A RADIO FREQUENCY ABLATION (RFA) PROCEDURE, A LEVEEN NEEDLE ELECTRODE WAS USED. WHEN THE PACKAGE WAS OPENED, THE TIP OF THE LEVEEN NEEDLE ELECTRODE WAS DAMAGED. THE DEVICE WAS USED IN THE PATIENT AFTER NOTING THE TIP DAMAGE AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275684 ↗
• MalfunctionOct 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE HAD BENT. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH LIVER CANCER. THE LEVEEN SUPERSLIM WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS IN POSITION IT WAS ATTEMPTED TO BE UNFOLDED. IT WAS REPORTED THAT THE DEVICE MET OBVIOUS RESISTANCE WHEN IT WAS BEING UNFOLDED AND IT WAS NOTED TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10643835 ↗
• MalfunctionJun 19, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING EXTENDED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH LIVER CANCER. THE LEVEEN SUPERSLIM WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS IN POSITION IT WAS ATTEMPTED TO BE UNFOLDED. IT WAS REPORTED THAT THE DEVICE HANDLE WAS TOO TIGHT TO BE USED AND IT COULD NOT BE COMPLETELY UNFOLDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176417 ↗
• MalfunctionMay 13, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE NEEDLE WAS DAMAGED. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH LIVER CANCER. THE LEVEEN SUPERSLIM WAS BEING USED FOR THIS PROCEDURE. DURING THE PROCEDURE THE NEEDLE WAS FOUND TO BE DEFORMED AFTER ABLATION OF THE NEEDLE CANAL. THIS DEVICE WAS REMOVED FROM THE PATIENT AND A NEW NEEDLE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED AND THE PATIENT WAS DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053643 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ABLATION WAS PERFORMED IN AN UNINTENDED AREA. THE PATIENT WAS UNDERGOING RADIOFREQUENCY ABLATION (RFA) FOR TREATMENT OF LIVER CANCER. A 2.0/17/15 LEVEEN SUPERSLIM NEEDLE WAS USED AND ABLATION WAS PERFORMED. HOWEVER, IT SEEMED THE ABLATION WAS PERFORMED IN AN AREA SLIGHTLY ABOVE WHERE IT SHOULD HAVE BEEN. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Necrosis

  MAUDE report 8557539 ↗
• MalfunctionFeb 21, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THERE WAS DIFFICULTY DEPLOYING THE ARRAY. A 2.0/17/15 LEVEEN¿ SUPERSLIM¿ WAS SELECTED FOR A RADIOFREQUENCY ABLATION PROCEDURE. WHEN ATTEMPTING TO DEPLOY THE DEVICE WHILE OUTSIDE OF THE PATIENT, THE HANDLE PORTION WAS DIFFICULT AND IT WAS UNABLE TO BE DEPLOYED SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7285013 ↗