LeVeen CoAccessRecalls & reported problems across all models

We found 3 models of LeVeen CoAccess by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2017 and Jun 23, 2026 — classified as 10 injuries, 34 malfunctions.

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

Most reported LeVeen CoAccess problems

LeVeen CoAccess models

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

• LeVeen™ CoAccess™ M001262220

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  21 reports
• LeVeen™ CoAccess™ M001262230

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  14 reports
• LeVeen™ CoAccess™ M001262240

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  9 reports

Recent LeVeen CoAccess adverse event reports

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

• InjuryJun 23, 2026Nonstandard Device

  IT WAS REPORTED THAT THE ABLATION AREA WAS LARGER THAN EXPECTED. A LEVEEN COACCESS AND A RF3000 RADIOFREQUENCY GENERATOR WERE SELECTED FOR A PULMONARY RADIOFREQUENCY PROCEDURE. DURING THE PROCEDURE, THE LEVEEN COACCESS NEEDLE WAS CORRECTLY PLACED IN THE TARGET AREA. THE TREATMENT TIME PARAMETERS WERE 1 MINUTE 28 SECONDS AT 10W, THEN 4 MINUTES AT 15W, AND FINALLY 10 SECONDS AT 10W. DURING THE FIRST TREATMENT SESSION, THE PARAMETERS FLUCTUATED MORE RAPIDLY THAN USUAL (INCREASING UP TO 20W). THERE WAS NO DROP IN POWER DELIVERY DURING THE THREE ABLATION ATTEMPTS. THE DESIRED ABLATION AREA WAS 3CM. THE THERMOABLATION AREA WAS ABNORMALLY LARGE, APPROXIMATELY 5 CM, FOR A TREATMENT DELIVERED AT ABOUT 10 TO 15 WATTS. THE ABLATION AREA WAS LARGER THAN EXPECTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25594311 ↗
• InjuryMar 3, 2026Difficult to Insert; Retraction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURN. A LEVEEN? COACCESS NEEDLE WAS SELECTED FOR USE. AFTER ABLATION WAS COMPLETED, THERE WAS DIFFICULTY REINSERTING THE NEEDLE INTO ITS SHEATH TO REMOVE IT FROM THE PATIENT. AFTER THE NEEDLE WAS REMOVED, THERE WAS A SECOND OR THIRD DEGREE BURN OBSERVED SURROUNDING THE PUNCTURE SITE. THE PHYSICIAN CONSULTED WITH THE DERMATOLOGY TEAM TO OBTAIN INSTRUCTIONS ON HOW BEST TO PROCEED.

  Patient problems: Burn(s)

  MAUDE report 24500182 ↗
• MalfunctionJul 16, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THERE WAS DIFFICULTY DEPLOYING THE ELECTRODE. A 3.0CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN THE LIVER. OUTSIDE THE PATIENT, WHEN DEPLOYING THE ELECTRODE, UNUSUAL RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522451 ↗
• MalfunctionJan 31, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE ARRAY FAILED TO EXTEND. A 3.0CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION (RFA) PROCEDURE IN THE LIVER. DURING ATTEMPTED DEPLOYMENT, IT WAS UNABLE TO DEPLOY. THEREFORE, IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284161 ↗
• InjuryDec 13, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A PATIENT BURN OCCURRED. A 3CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN RADIOFREQUENCY ABLATION (RFA) PROCEDURE TO TREAT A LIVER TUMOR. THE NEEDLE WAS INSERTED PERCUTANEOUSLY THROUGH THE PATIENT'S ABDOMEN AND POSITIONED INTO THE LIVER TUMOR. ABOUT 5MINS INTO THE RFA, THE SURGEON ACTIVATED THE LEVEEN NEEDLE, WHICH RESULTED IN AN UNKNOWN ERROR MESSAGE. THE PROCEDURE HAD TO RESTART. ABOUT 3MINS INTO THE SECOND ROUND OF RFA, A BURN MARK WAS OBSERVED AT THE PUNCTURE POINT OF THE LEVEEN NEEDLE. THE PROCEDURE WAS STOPPED, AND THE LEVEEN NEEDLE WAS REMOVED. IT WAS THEN OBSERVED THAT THE LEVEEN NEEDLE WAS USED WITHOUT THE COACCESS CANNULA. USING ULTRASOUND, IT WAS DETERMINED THAT THE TARGET AREA OF THE RFA WAS NOT SATISFACTORY, AND IT WAS DECIDED TO CONTINUE WITH ANOTHER ROUND OF RFA. FOR THIS ADDITIONAL RFA TREATMENT, THE COACCESS CANNULA WAS USED TOGETHER WITH THE LEVEEN NEEDLE. THE ADDITIONAL RFA TREATMENT WENT SMOOTHLY. AFTER REMOVING THE LEVEEN COACCESS SYSTEM, THE PUNCTURE POINT WAS CHECKED, AND IT WAS DETERMINED THAT THE BURNT SKIN/TISSUE HAD TO BE REMOVED. A SMALL PORTION OF ABOUT 10-15MM IN WIDTH AND ABOUT 5MM IN DEPTH OF THE BURNT

  Patient problems: Burn(s)

  MAUDE report 20924559 ↗
• MalfunctionAug 29, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED. A 3.5/15/15 LEVEEN COACCESS WAS SELECTED FOR A RADIO FREQUENCY ABLATION PROCEDURE TO TREAT RENAL CELL CARCINOMA. A 15 MINUTE BURN WAS PERFORMED ENDING AT 180W PER THE PROTOCOL. THE MACHINE WAS RESTARTED AND BURNED AGAIN FOR ANOTHER 15 MINUTES. NO IMPEDANCE WAS SEEN DURING BOTH OF THESE BURNS. IN FACT, IT APPEARED AS IF THE IMPEDANCE WAS DECREASING THROUGHOUT THE BURN. ALL CONNECTIONS WERE CHECKED AND THE CORD FELT WARM AS WELL AS ITS CONNECTION TO THE NEEDLE. ONCE THE MACHINE RESET AT 15 MINUTES AFTER THE SECOND BURN, THE PHYSICIAN WANTED TO SCAN TO MAKE SURE A BURN WAS CREATED. GAS WAS SEEN ON IMAGING SO THE PHYSICIAN THOUGHT A BURN WAS CREATED. THE MACHINE WAS STARTED FOR A THIRD BURN AT 180W. AFTER 5 MORE MINUTES, AND STILL NO IMPEDANCE, THE NEEDLE WAS SWAPPED OUT WITH ANOTHER OF THE SAME DEVICE, KEEPING THE ORIGINAL TROCAR. THE BURN WAS STARTED AGAIN AT 180W AND WITHIN 7 MINUTES ROLL-OFF WAS REACHED. A FINAL SCAN WAS COMPLETED, AND THE PHYSICIAN WAS SATISFIED WITH THE BURN. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20097794 ↗
• MalfunctionAug 27, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL OFF OCCURRED. A 3.5CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE TO TREAT A HEPATIC TUMOR. DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO REACH ROLL OFF. TROUBLESHOOTING WAS ATTEMPTED BY RESETTING THE CONSOLE. THE NEEDLE WAS REPLACED AND ROLL OFF WAS REACHED VERY RAPIDLY. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076328 ↗
• MalfunctionMay 7, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE ARRAY WAS DIFFICULT TO DEPLOY. A 3.0CM X 15CM LEVEEN COACCESS NEEDLE ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE. BEFORE STARTING THE PROCEDURE, THE NEEDLE WAS DEPLOYED TO CHECK ITS OPERATION, BUT AN UNUSUAL RESISTANCE OR STIFFNESS WAS ENCOUNTERED. THEREFORE, A DIFFERENT STOCK WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19263817 ↗
• MalfunctionFeb 9, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ROLL-OFF. A LEVEEN COACCESS WAS SELECTED FOR USE TO TREAT A CASE OF CANCER IN THE LIVER. WHEN ROLL-OFF WAS ATTEMPTED, IT WAS NOTED THAT IT TOOK LONGER THAN USUAL. BY INCREASING THE CAUTERIZATION RANGE IN STAGES, ROLL-OFF WAS POSSIBLE AT ABOUT 180 W WHEN THE RANGE WAS NARROW. HOWEVER, WHEN THE RANGE WAS INCREASED, ROLL-OFF DID NOT OCCUR, EVEN AT 200 W. THE PROCEDURE WAS COMPLETED USING THIS DEVICE AND THERE WERE NO REPORTED PATIENT INJURIES AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676171 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SKIN BURN OCCURRED. A RF3000 RADIOFREQUENCY GENERATOR AND A LEVEEN COACCESS RF PROBE WERE SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE. DURING THE PROCEDURE, THERE WERE NO ANOMALIES NOTED; HOWEVER, A SKIN BURN OCCURRED. DESPITE A HYDRO AND CARBO DISSECTION WITH A COLON DISTANCE OF 19MM, THERE WAS A COLONIC WOUND AS WELL AS A BURN TO THE SKIN 2CM IN DIAMETER. THE SEVERITY OF THE BURN WAS NOT ASSESSED. THE COLONIC WOUND ALSO RESULTED IN SEPTIC SHOCK AND STERCORAL PERITONITIS, WHICH REQUIRED A LEFT HEMICOLECTOMY WITH COLOSTOMY.

  Patient problems: Burn(s); Peritonitis; Septic Shock; Unspecified Tissue Injury

  MAUDE report 16146493 ↗
• MalfunctionDec 15, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE WAS NOT ABLE TO DEPLOY. A 3.5/15/15 LEVEEN COACCESS ELECTRODE WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE. DURING THE PROCEDURE, UPON PLACING THE NEEDLE INSIDE THE PATIENT, THE NEEDLE WAS NOT ABLE TO DEPLOY. ANOTHER NEEDLE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986567 ↗
• InjuryDec 16, 2021Defective Device; Defective Device

  IT WAS REPORTED A PUNCTURE BURN OCCURRED. THE PATIENT WAS UNDERGOING A RADIOFREQUENCY ABLATION PROCEDURE IN THEIR LIVER. A LEVEEN COACCESS PROBE WAS USED WITH A RF 3000 GENERATOR. THE LEVEEN COACCESS PROBE WAS POSITIONED IN THE TUMOR SITE. IT WAS OBSERVED THAT THE ARRAY OF THE DEVICE DID NOT APPEAR TO BE HEATING UP, ONLY THE CANNULA OF THE DEVICE WAS. THE PATIENT'S SKIN BECAME BURNED. THE PROBE WAS REMOVED AND EXCHANGED FOR ANOTHER OF THE SAME. THE SECOND LEVEEN COACCESS PROBE WAS POSITIONED AND THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THE INSULATION OF THE DEVICE REMAINED INTACT UPON REMOVAL FROM THE PATIENT. THE BURN WAS THIRD DEGREE AND THE PHYSICIAN CUT THE BURN SITE TO TREAT IT. THE PATIENT WAS STABLE. IT HAS SINCE BEEN REPORTED THE WOUND IS HEALED.

  Patient problems: Burn(s)

  MAUDE report 13023414 ↗
• InjuryDec 16, 2021Defective Device; Defective Device

  IT WAS REPORTED A PUNCTURE BURN OCCURRED. THE PATIENT WAS UNDERGOING A RADIOFREQUENCY ABLATION PROCEDURE IN THEIR LIVER. A LEVEEN COACCESS PROBE WAS USED WITH A RF 3000 GENERATOR. THE LEVEEN COACCESS PROBE WAS POSITIONED IN THE TUMOR SITE. IT WAS OBSERVED THAT THE ARRAY OF THE DEVICE DID NOT APPEAR TO BE HEATING UP, ONLY THE CANNULA OF THE DEVICE WAS. THE PATIENT'S SKIN BECAME BURNED. THE PROBE WAS REMOVED AND EXCHANGED FOR ANOTHER OF THE SAME. THE SECOND LEVEEN COACCESS PROBE WAS POSITIONED AND THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THE INSULATION OF THE DEVICE REMAINED INTACT UPON REMOVAL FROM THE PATIENT. THE BURN WAS THIRD DEGREE AND THE PHYSICIAN CUT THE BURN SITE TO TREAT IT. THE PATIENT WAS STABLE. IT HAS SINCE BEEN REPORTED THE WOUND IS HEALED.

  Patient problems: Burn(s)

  MAUDE report 13023412 ↗
• MalfunctionSep 24, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE TINES WERE DIFFICULT TO EXTEND. A 3.0/15/15 LEVEEN COACCESS ELECTRODE SYSTEM WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE OF A LIVER TUMOR. THE LEVEEN NEEDLE WAS INSERTED INTO THE PATIENT. SOME RESISTANCE WAS FELT, AND IT WAS NOT SMOOTH DEPLOYING THE NEEDLE. THEREFORE, THE PHYSICIAN DID NOT WANT TO USE THE DEVICE TO ABLATE THE TUMOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND IT WAS SMOOTH TO DEPLOY. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525267 ↗
• MalfunctionJul 9, 2021Failure to Unfold or Unwrap; Material Twisted/Bent; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE TINES WERE DIFFICULT TO DEPLOY. A LEVEEN COACCESS ELECTRODE SYSTEM 3.0/15/15 WAS SELECTED FOR USE IN A PROCEDURE TO TREAT A RENAL TUMOR IN THE KIDNEY. DURING THE PROCEDURE, THERE WAS RESISTANCE WHEN ATTEMPTING TO DEPLOY THE NEEDLE TINES AND THEY BECAME DISTORTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146766 ↗

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