LeVeen™ SuperSlim™ M001262280Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729441717), received between Aug 27, 2018 and Jun 4, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (15 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP RUPTURED. A 3.0 CM X 15CM LEVEEN? SUPERSLIM? NEEDLE ELECTRODE WAS SELECTED FOR USE IN A PROCEDURE. DURING PREPARATION OUTSIDE THE PATIENT, THE TIP END WAS RUPTURED AND LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398409 ↗
• MalfunctionApr 2, 2026Material Twisted/Bent; Power Problem

  IT WAS REPORTED THAT THE NEEDLES WERE BENT. A LEVEEN? SUPERSLIM? WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE. DURING THE PROCEDURE, THE CONSOLE FREQUENTLY SHUT DOWN. WHEN THE NEEDLE WAS REMOVED FROM THE PATIENT, IT WAS DISCOVERED THAT THE SUB-NEEDLES WERE UNEVENLY DISTRIBUTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770227 ↗
• MalfunctionJul 23, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT ROLL-OFF WAS NOT ACHIEVED. A 3.0CM X 15CM LEVEEN SUPERSLIM NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE IN THE LIVER. AFTER THE NEEDLE ELECTRODE WAS INSERTED INTO THE LESION AND PROPERLY PLACED, ABLATION WAS PERFORMED AT 60 WATTS FOR 5 MINUTES AND 120 WATTS FOR 7 MINUTES, BUT THE LESION SHOWED NO RESPONSE UNDER ULTRASOUND IMAGING. THE IMPEDANCE INDICATOR ON THE GENERATOR REMAINED STABLE AT AROUND 130 AND DID NOT INCREASE. THE PROCEDURE WAS COMPLETED WITH A NEW NEEDLE ELECTRODE AND THE ORIGINAL GENERATOR. THE TUMOR WAS SUCCESSFULLY TREATED. 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 22579187 ↗
• MalfunctionJul 18, 2025Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE TINES OF THE NEEDLE WERE BENT/TANGLED AND DIFFICULT TO RETRACT. THIS 3.0/17/15 LEVEEN? SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A LIVER COMPUTED TOMOGRAPHY (CT) GUIDED ABLATION THERAPY PROCEDURE FOR LIVER CANCER. DURING THE PROCEDURE, THE FIRST TIME THE NEEDLE WAS WITHDRAWN, IT WAS WITHDRAWN SMOOTHLY. THE SECOND TIME THE NEEDLE WAS WITHDRAWN, THE SHAPE OF THE NEEDLE WAS DISTORTED, AND THE NEEDLE COULD NOT BE WITHDRAWN SMOOTHLY. AFTER SEVERAL ATTEMPTS OF POSITION ADJUSTMENT, WHEN THE RADIOFREQUENCY NEEDLE WAS REMOVED, IT WAS OBSERVED THAT THE NEEDLE TINES WERE ENTANGLED WITH EACH OTHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22548343 ↗
• MalfunctionJun 9, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE COULD NOT BE DEPLOYED. A LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN THE RADIOFREQUENCY ABLATION OF THE LIVER. WHILE IT WAS BEING CHECKED OUTSIDE OF THE PATIENT TO DETERMINE IF THE NEEDLE COULD DEPLOY PROPERLY, IT FELT STIFF AND THERE WAS RESISTANCE. A NEW DEVICE OF THE SAME MODEL WAS USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170254 ↗
• MalfunctionMay 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS BENT. THIS 3.0/17/15 LEVEEN SUPERSLIM NEEDLE WAS BEING PREPARED FOR USE. DURING UNPACKING, THE NEEDLE WAS FOUND TO BE BENT. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989997 ↗
• MalfunctionNov 27, 2024Failure to Unfold or Unwrap; Material Twisted/Bent; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT THE ARRAY WAS DIFFICULT TO EXTEND. A 2.0CM X 15CM LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN THE RADIOFREQUENCY ABLATION OF A 3CM LIVER TUMOR. AFTER POSITIONING AND INSERTING THE NEEDLE ELECTRODE INTO THE LESION, THE ARRAY COULD NOT BE FULLY OPENED AND SLID. AFTER SEVERAL ATTEMPTS, THE SAME SITUATION OCCURRED. AFTER REMOVING THE NEEDLE ELECTRODE, IT WAS FOUND THAT THE ARRAY WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798759 ↗
• MalfunctionAug 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ELECTRODE WAS BENT. A 3.0CM X 15CM LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN THE LIVER. DURING THE PROCEDURE, THE LIVER WAS HARD, AND THE DEVICE BENT DURING THE PUNCTURE. THE DEVICE DID NOT REACH THE TUMOR. AFTER THAT, AN ATTEMPT WAS MADE TO CONTINUE THE PROCEDURE WITH A DIFFERENT SIZE, BUT THE PATIENT'S CONDITION WAS NOT GOOD, SO THE PROCEDURE WAS ABANDONED FOR THE DAY. RE-TREATMENT WAS SCHEDULED FOR THE FOLLOWING WEEK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948782 ↗
• MalfunctionApr 22, 2024Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE ELECTRODE WAS BENT. A 3.0CM X 15CM LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE. UPON TAKING THE DEVICE OUT OF THE PACKAGE, THE ROD OF THE NEEDLE WAS BENT. IT WAS DIFFICULT TO ADVANCE. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153900 ↗
• MalfunctionDec 21, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS DEFORMED. THE TARGET LESION WAS LOCATED IN THE RIGHT INFERIOR LUNG. A 3.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER LOCAL ANESTHESIA, THE DEVICE WAS FOUND TO BE DEFORMED AND CURVED WHEN TAKEN OUT OF THE PATIENT. A NEW ABLATION NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380473 ↗
• MalfunctionDec 18, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. A 3.0 X 17 X 15 LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN THE LIVER. UPON UNPACKING THE DEVICE, IT WAS FOUND THAT THE INNER PACKAGING WAS BROKEN. DUE TO A CONCERN THAT THE DEVICE WAS CONTAMINATED, THE DEVICE WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352202 ↗
• MalfunctionDec 13, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE ARRAY DID NOT DEPLOY PROPERLY. A 3.0 X 17 X 15 LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN THE LIVER. THE DEVICE WAS USED TO PUNCTURE ONE PATIENT IN MULTIPLE LOCATIONS. AFTER THE PROCEDURE WAS COMPLETED, THE NEEDLE WAS DEPLOYED, AND IT WAS NOTICED THAT ONE OF THE NEEDLES WAS DEPLOYED OUTWARD IN THE OPPOSITE DIRECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321730 ↗
• MalfunctionOct 6, 2023Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS DEFORMED AND IN A DEPLOYED STATE UPON UNPACKING. A 3.0/17/15 LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN THE RADIOFREQUENCY ABLATION OF LUNG TUMORS. DURING PREPARATION, UPON UNPACKING THE DEVICE, IT WAS NOTED THAT THE NEEDLE WAS DEFORMED AND WAS IN A DEPLOYED STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886054 ↗
• MalfunctionJan 5, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE DEPLOYED. A 3.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR USE. DURING PREPARATION OUTSIDE THE BODY, THE DEVICE COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109363 ↗
• MalfunctionSep 28, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE DEPLOYED. THE TARGET LOCATION WAS LOCATED IN THE INFERIOR OF THE RIGHT LUNG LOBE. A 3.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE COULD NOT BE DEPLOYED INSIDE THE PATIENT. 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 15496031 ↗
• MalfunctionAug 23, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE TINES FAILED TO EXTEND. A 3.0/17/15 LEVEEN SUPERSLIM NEEDLE WAS SELECTED FOR A LUNG CANCER ABLATION PROCEDURE. DURING THE PROCEDURE, COMPUTED TOMOGRAPHY (CT) SHOWED THAT THE NEEDLE WAS STRAIGHT. AFTER THE NEEDLE WAS REMOVED, IT WAS CONFIRMED THAT THE NEEDLE WAS STRAIGHT. THE PROCEDURE WAS COMPLETED WITH A NEW NEEDLE THAT WAS THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278782 ↗
• MalfunctionJun 9, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE/TINES WERE BENT. A 3.0/17/15 LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A PERCUTANEOUS RADIOFREQUENCY ABLATION OF PULMONARY LESIONS. DURING THE PROCEDURE, TWO OF THE NEEDLES ON THE ELECTRODE WERE DEFORMED; THE REST OF THE NEEDLES WERE NORMAL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644228 ↗
• MalfunctionMay 26, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS BENT. A 3.0/17/15 LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE IN A TUMOR ABLATION PROCEDURE. DURING THE PROCEDURE, THE NEEDLE BECAME BENT AND THE CONSOLE FREQUENTLY SHUTDOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517208 ↗
• MalfunctionSep 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE WAS BENT. A LEVEEN SUPERSLIM NEEDLE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484621 ↗
• MalfunctionDec 7, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DIFFICULTY TO EXTEND A NEEDLE OCCURRED. DURING A RADIOFREQUENCY ABLATION PROCEDURE, A 3.0CM LEVEEN SUPERSLIM ELECTRODE WAS ADVANCED INTO THE TARGET LESION. HOWEVER, IT WAS NOTICED THAT THE NEEDLE ELECTRODE WAS NOT FULLY DEPLOYED AND COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10960747 ↗
• MalfunctionOct 13, 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 INSERTED INTO THE PATIENT IT BECAME 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 10671169 ↗
• MalfunctionFeb 26, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE BENT. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED. THE LEVEEN SUPERSLIM WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS IN POSITION IT WAS ATTEMPTED TO BE ADVANCED. WHEN THE PHYSICIAN WENT TO ADVANCE THE NEEDLE AND IT BENT. THIS NEEDLE WAS REMOVED FROM THE PATIENT AND A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS THAT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758932 ↗
• MalfunctionDec 6, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE ELECTRODE WAS BENT. A RADIOFREQUENCY ABLATION OF PRIMARY LIVER CANCER WAS PERFORMED. THE SIZE OF THE TUMOR WAS 4.0CM, SO THE PHYSICIAN USED A 3.0/17/15 LEVEEN SUPERSLIM NEEDLE ELECTRODE TO PERFORM ABLATION. FOR THE FIRST AND THE SECOND TIME, IT WAS SUCCESSFULLY PUNCTURED AND ABLATED. BUT WHEN THE PHYSICIAN CHANGED THE PUNCTURE PATH AND ADJUSTED THE NEEDLE, THE TIP OF THE NEEDLE WAS FOUND TO BE CURVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9432187 ↗
• MalfunctionDec 3, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE HAD DIFFICULTY BEING EXTENDED. A RADIOFREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED . THE 3.0/17/15 LEVEEN SUPERSLIM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE NEEDLE DID NOT DEPLOY OR EXTEND PROPERLY. THEY REPLACED THE NEEDLE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403846 ↗
• MalfunctionApr 30, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING ON THE TIP OF THE NEEDLE WAS DEFORMED DURING PREPARATION FOR A RADIOFREQUENCY ABLATION PROCEDURE. DURING PREPARATION OF THE LEVEEN SUPERSLIM NEEDLE ELECTRODE; THE COATING ON THE TIP OF THE NEEDLE WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8565131 ↗