LeVeen StandardRecalls & reported problems across all models

We found 6 models of LeVeen Standard by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2018 and Jul 6, 2026 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (6 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

Most reported LeVeen Standard problems

LeVeen Standard models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LeVeen™ Standard M001262030

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  8 reports
• LeVeen™ Standard M001262050

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  4 reports
• LeVeen™ Standard M001262160

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  4 reports
• LeVeen™ Standard M001262130

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  3 reports
• LeVeen™ Standard M001262150

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 reports
• LeVeen™ Standard M001262310

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 report

Recent LeVeen Standard adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT WAS INJURED, REQUIRING FURTHER INTERVENTION. A LEVEEN? STANDARD PROBE WAS SELECTED FOR USE IN AN ABLATION PROCEDURE. DURING THE PROCEDURE, ROLL-OFF WAS NEVER ACHIEVED, WHICH PROLONGED THE PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. ON (B)(6) 2026, 8 DAYS AFTER THE ABLATION PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH PAIN, FEVER, AND ELEVATED WHITE BLOOD CELL COUNT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED NEW RIGHT PLEURAL FLUID AND POSSIBLE LIVER ABSCESS. THE PATIENT WAS DIAGNOSED WITH SEPSIS AROUND THE DIAPHRAGM. THE PHYSICIAN BELIEVED THAT THE PROLONGED ABLATION RESULTED IN DAMAGE TO THE DIAPHRAGM. THE PATIENT WAS PUT ON ANTIBIOTICS TO TREAT THE SEPSIS. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND STABLE AT THE TIME OF REPORTING. THE PATIENT WAS SCHEDULED FOR REPEAT IMAGING, BUT IT HAD NOT YET BEEN PERFORMED.

  Patient problems: Abscess; Fever; High White Blood Cell Count; Pain; Pleural Effusion; Sepsis; Unspecified Tissue Injury

  MAUDE report 25728058 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 18, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE TINES OF THE NEEDLE WERE DIFFICULT TO RETRACT. THIS 3.5/15/25 PH LEVEEN STANDARD NEEDLE ELECTRODE WAS SELECTED FOR A RADIOFREQUENCY ABLATION PROCEDURE TO TREAT A POSSIBLE TUMOR. AFTER SUCCESSFULLY DEPLOYING AND PERFORMING ABLATION SIX TIMES USING THE DEVICE, IT WAS ATTEMPTED TO RETRIEVE THE NEEDLE, BUT THIS WAS UNSUCCESSFUL. MORE FORCE WAS APPLIED WITHOUT SUCCESS; THEREFORE, THEY CAPTURED THE NEEDLE BY PUSHING NON-IONIC WATER INTO THE SIDE OF THE NEEDLE TO CLEAR ANY OBSTACLES. THE PROCEDURE WAS COMPLETED, AND THE NEEDLE WAS REMOVED. ONCE OUTSIDE THE BODY, IT WAS NOTED THAT THERE WERE PARTICLES STUCK IN THE NEEDLE, AND ONCE REMOVED, THE TINES COULD BE RETRACTED NORMALLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401271 ↗
• MalfunctionAug 22, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED. IN (B)(6) 2024, THE PATIENT UNDERWENT A HEPATIC RADIO FREQUENCY ABLATION (RFA) PROCEDURE WITH AN RF3000 GENERATOR AND A 17G, 5CM X 15CM RF LEVEEN NEEDLE. THE LESION MEASURED ABOUT 25MM. ABLATION WAS PERFORMED WITH TWO HEAT-UP TIMES AT 200W FOR 15 MINUTES WITHOUT REACHING ROLL-OFF. NO PATIENT COMPLICATIONS WERE REPORTED. POST RFA PROCEDURE, IN (B)(6) 2024, MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED, WHICH CONCLUDED THAT THE TREATMENT HAD BEEN SUCCESSFUL EVEN THOUGH THE LESION HAD INCREASED IN SIZE AND NO POST-THERAPEUTIC SCARRING WAS VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026016 ↗
• MalfunctionMar 25, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL-OFF OCCURRED. A 3.5CM X 25CM LEVEEN STANDARD NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE. THE DEVICE WAS USED IN THE ABDOMEN. THE IMPENDANCE DID NOT INCREASE DURING ABLATION, AND IT WAS THOUGHT THAT IT WAS POSSIBLY INSIDE THE BLOOD VESSELS. HOWEVER, IT WAS THEN CONFIRMED WITH ECHOCARDIOGRAPHY THAT IT WAS NOT INSIDE THE BLOOD VESSELS. SINCE THE DEVICE COULD NOT BE USED, THE DEVICE WAS EXCHANGED. ANOTHER SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968582 ↗
• MalfunctionMay 30, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED. A 5.0/13/15 LEVEEN STANDARD RF ELECTRODE WAS SELECTED FOR USE IN A PULMONARY RADIO FREQUENCY ABLATION PROCEDURE. THERE WAS DIFFICULTY DURING PLACEMENT, AND NO IMPEDANCE. PATCH WAS CHANGED TWO TIMES, BUT THIS DID NOT RESOLVE THE ISSUE. THE ELECTRODE WAS EXCHANGED, WHICH DID RESOLVE THE ISSUE. LESS THAN FIVE MINUTES OF TIME WAS WASTED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT ROLL OFF WAS ACHIEVED WITH A NEW ELECTRODE, AND THE PATIENT HAD A GOOD OUTCOME POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020686 ↗
• MalfunctionMar 9, 2023Failure to Unfold or Unwrap; Defective Device; Therapeutic or Diagnostic Output Failure; Failure to Unfold or Unwrap; Defective Device; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE ARRAY DID NOT DEPLOY PROPERLY, AND INSUFFICIENT ROLL OFF OCCURRED. A 4.0/14/15 LEVEEN STANDARD PROBE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN A METASTATIC LUNG TUMOR. DURING THE PROCEDURE, THE HANDLE OF THE NEEDLE WAS COMPLETELY LOOSE, AND THE PEAK OF THE NEEDLE SLIPPED OUT COMPLETELY WITH MINIMAL FORWARD MOVEMENT. THE NEEDLE WAS STUCK IN THE TUMOR, AND AFTER DEPLOYMENT OF THE ARRAY, THE WHITE PLASTIC END SLIPPED BACK, SO THE NEEDLE WAS NOT COMPLETELY OPEN. TREATMENT WAS PERFORMED WITH TWO CYCLES, BUT THERE WAS NO ROLL OFF. THE NEEDLE WAS NOT EXCHANGED SINCE THERE WERE NO ADDITIONAL NEEDLES AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515745 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. A RADIOFREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED. A 4.0CM LEVEEN STANDARD ELECTRODE WAS OPENED ON THE STERILE FIELD AND AS THE SURGEON WAS ABOUT TO USE IT HE NOTICED THAT AT THE TIP OF THE NEEDLE THERE WAS A WHITE SUBSTANCE/DEBRIS. IT WAS NOT USED ON A PATIENT AND HANDED OFF THE FIELD. THE PATIENT WAS FINE AND THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411263 ↗
• 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 ↗
• InjuryOct 19, 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 10697370 ↗

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