LeVeen SuperSlimRecalls & reported problems across all models
Boston Scientific Corporation · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 60
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls
- 0
We found 3 models of LeVeen SuperSlim by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Jan 30, 2018 and Sep 23, 2026 — classified as 1 death, 1 injury, 58 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LeVeen SuperSlim problems
Device problems
- Material Twisted/Bent26
- Failure to Unfold or Unwrap24
- Defective Device4
- Adverse Event Without Identified Device or Use Problem3
- Therapeutic or Diagnostic Output Failure3
- Activation Problem2
- Difficult to Open or Close2
- Power Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient14
- No Patient Involvement4
- Bradycardia1
- Necrosis1
LeVeen SuperSlim models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LeVeen™ SuperSlim™ M001262280ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES32 reports
- LeVeen™ SuperSlim™ M001262260ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES26 reports
- LeVeen™ SuperSlim™ M001262270ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 death2 reports
Recent LeVeen SuperSlim adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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