LeVeen™ CoAccess™ M001262230Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729295617), received between Feb 14, 2019 and Jun 23, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 1, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THE ELECTRODES DID NOT FULLY DEPLOY AND A SLIGHT PARENCHYMAL HEMORRHAGE AND A NARROW PNEUMOTHORAX OCCURRED, TREATMENT WAS TERMINATED. TWO LEVEEN COACCESS/3.5/15/15 ELECTRODES WERE USED IN A LUNG ABLATION PROCEDURE. MECHANICAL TESTING WAS PERFORMED SUCCESSFULLY OUTSIDE OF THE PATIENT. THE FIRST COACCESS NEEDLE WAS THEN PLACED IN THE TUMOR. DESPITE THE FULL ADVANCE OF THE SHIELD ELECTRODE (I.E. COMPLETE RELEASE WHEN VIEWED FROM THE OUTSIDE), THE SHIELD IS ONLY UNFOLDED WITH A MAXIMUM DIAMETER OF 1 CM WITHIN THE LUNGS. REPOSITIONING WAS PERFORMED SEVERAL TIMES: RETRACTION AND RELEASE OF THE NEEDLE IN THE SAME POSITION / SLIGHTLY ROTATED, RETRACTION AND REMOVAL OF THE SHIELD ELECTRODE WITH A RENEWED TEST OF THE RELEASE OUTSIDE THE BODY - WHICH SUCCEEDS WITHOUT PROBLEMS, THE MINIMAL ADVANCE OF THE COACCESS NEEDLE AND RENEWED RELEASE OF THE SHIELD ELECTRODE. NONE OF THE MANEUVERS LEAD TO THE FULL DEPLOYMENT OF THE WING. INDIVIDUAL HOOKS ON THE UMBRELLA CROSS EACH OTHER IN SITU. TO AVOID THE SPREAD OF TUMOR CELLS, THE 1 CM EXPANDED SCREEN IS USED TO ABLATE 2 CYCLES IN THE POSITION IT HAS REACHED, THE TECHNICAL PROCESS BEING INCONSPICUOUS. TO ENSURE COMPLETE TUMOR ABLATION,

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 12104425 ↗
• InjuryJul 1, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THE ELECTRODES DID NOT FULLY DEPLOY AND A SLIGHT PARENCHYMAL HEMORRHAGE AND A NARROW PNEUMOTHORAX OCCURRED, TREATMENT WAS TERMINATED. TWO LEVEEN COACCESS/3.5/15/15 ELECTRODES WERE USED IN A LUNG ABLATION PROCEDURE. MECHANICAL TESTING WAS PERFORMED SUCCESSFULLY OUTSIDE OF THE PATIENT. THE FIRST COACCESS NEEDLE WAS THEN PLACED IN THE TUMOR. DESPITE THE FULL ADVANCE OF THE SHIELD ELECTRODE (I.E. COMPLETE RELEASE WHEN VIEWED FROM THE OUTSIDE), THE SHIELD IS ONLY UNFOLDED WITH A MAXIMUM DIAMETER OF 1 CM WITHIN THE LUNGS. REPOSITIONING WAS PERFORMED SEVERAL TIMES: RETRACTION AND RELEASE OF THE NEEDLE IN THE SAME POSITION / SLIGHTLY ROTATED, RETRACTION AND REMOVAL OF THE SHIELD ELECTRODE WITH A RENEWED TEST OF THE RELEASE OUTSIDE THE BODY - WHICH SUCCEEDS WITHOUT PROBLEMS, THE MINIMAL ADVANCE OF THE COACCESS NEEDLE AND RENEWED RELEASE OF THE SHIELD ELECTRODE. NONE OF THE MANEUVERS LEAD TO THE FULL DEPLOYMENT OF THE WING. INDIVIDUAL HOOKS ON THE UMBRELLA CROSS EACH OTHER IN SITU. TO AVOID THE SPREAD OF TUMOR CELLS, THE 1 CM EXPANDED SCREEN IS USED TO ABLATE 2 CYCLES IN THE POSITION IT HAS REACHED, THE TECHNICAL PROCESS BEING INCONSPICUOUS. TO ENSURE COMPLETE TUMOR ABLATION,

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 12104155 ↗
• InjuryJun 8, 2021Retraction Problem; Failure to Unfold or Unwrap; Material Twisted/Bent; Retraction Problem; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT THE TINES WERE DIFFICULT TO EXTEND, DIFFICULT TO RETRACT, AND BENT. THE PATIENT EXPERIENCED A HEMORRHAGE AND A PNEUMOTHORAX. LEVEEN COACCESS ELECTRODE SYSTEMS WERE SELECTED FOR USE IN A RADIOFREQUENCY ABLATION (RFA) PROCEDURE TO TREAT A LUNG TUMOR. BEFORE USE, THE DEVICE WAS BENCH TESTED ON A TABLE, AND THE COAXIAL AND NEEDLE BOTH FITTED AND DEPLOYED WITHOUT ISSUE. DURING THE PROCEDURE, THE FIRST COAXIAL AND NEEDLE WERE INSERTED INTO THE LUNG, BUT THE NEEDLE DID NOT DEPLOY PROPERLY. ALL THE TINES WENT IN ONE DIRECTION, SO THEY WERE RETRACTED. THE COAXIAL WAS TWISTED, AND THE TINES WERE DEPLOYED AGAIN. IT STILL DID NOT DEPLOY CIRCUMFERENTIALLY. THE TINES WERE RETRACTED AGAIN WITH DIFFICULTY. THE PHYSICIAN STRUGGLED SIGNIFICANTLY, SO A SECOND NEEDLE WAS SELECTED FOR USE. THE FIRST COAXIAL WAS LEFT IN PLACE, AND THE SAME THING HAPPENED AGAIN. BOTH TIMES WHEN THE PROBE WAS REMOVED, THE TINES WERE NOTED TO BE ASYMMETRICAL AND SKEWED. A THIRD NEEDLE WAS SELECTED FOR USE. THIS TIME, THE FIRST COAXIAL WAS REMOVED AND REPLACED WITH A NEW ONE DESPITE THE PHYSICIAN ACKNOWLEDGING A RISK OF A PNEUMOTHORAX. THE THIRD NEEDLE WAS BENCH TESTED AND THEN INSERTED INTO THE LUNG. T

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 11956695 ↗
• MalfunctionJun 7, 2021Retraction Problem; Failure to Unfold or Unwrap; Material Twisted/Bent; Retraction Problem; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT THE TINES WERE DIFFICULT TO EXTEND, DIFFICULT TO RETRACT, AND BENT. LEVEEN COACCESS ELECTRODE SYSTEMS WERE SELECTED FOR USE IN A RADIOFREQUENCY ABLATION (RFA) PROCEDURE TO TREAT A LUNG TUMOR. BEFORE USE, THE DEVICE WAS BENCH TESTED ON A TABLE, AND THE COAXIAL AND NEEDLE BOTH FITTED AND DEPLOYED WITHOUT ISSUE. DURING THE PROCEDURE, THE FIRST COAXIAL AND NEEDLE WERE INSERTED INTO THE LUNG, BUT THE NEEDLE DID NOT DEPLOY PROPERLY. ALL THE TINES WENT IN ONE DIRECTION, SO THEY WERE RETRACTED. THE COAXIAL WAS TWISTED, AND THE TINES WERE DEPLOYED AGAIN. IT STILL DID NOT DEPLOY CIRCUMFERENTIALLY. THE TINES WERE RETRACTED AGAIN WITH DIFFICULTY. THE PHYSICIAN STRUGGLED SIGNIFICANTLY, SO A SECOND NEEDLE WAS SELECTED FOR USE. THE FIRST COAXIAL WAS LEFT IN PLACE, AND THE SAME THING HAPPENED AGAIN. BOTH TIMES WHEN THE PROBE WAS REMOVED, THE TINES WERE NOTED TO BE ASYMMETRICAL AND SKEWED. A THIRD NEEDLE WAS SELECTED FOR USE. THIS TIME, THE FIRST COAXIAL WAS REMOVED AND REPLACED WITH A NEW ONE DESPITE THE PHYSICIAN ACKNOWLEDGING A RISK OF A PNEUMOTHORAX. THE THIRD NEEDLE WAS BENCH TESTED AND THEN INSERTED INTO THE LUNG. THE SAME ISSUES OCCURRED AGAIN. THE DEVICE APPEARED TO BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953595 ↗
• MalfunctionJun 7, 2021Retraction Problem; Failure to Unfold or Unwrap; Material Twisted/Bent; Retraction Problem; Failure to Unfold or Unwrap; Material Twisted/Bent

  IT WAS REPORTED THAT THE TINES WERE DIFFICULT TO EXTEND, DIFFICULT TO RETRACT, AND BENT. LEVEEN COACCESS ELECTRODE SYSTEMS WERE SELECTED FOR USE IN A RADIOFREQUENCY ABLATION (RFA) PROCEDURE TO TREAT A LUNG TUMOR. BEFORE USE, THE DEVICE WAS BENCH TESTED ON A TABLE, AND THE COAXIAL AND NEEDLE BOTH FITTED AND DEPLOYED WITHOUT ISSUE. DURING THE PROCEDURE, THE FIRST COAXIAL AND NEEDLE WERE INSERTED INTO THE LUNG, BUT THE NEEDLE DID NOT DEPLOY PROPERLY. ALL THE TINES WENT IN ONE DIRECTION, SO THEY WERE RETRACTED. THE COAXIAL WAS TWISTED, AND THE TINES WERE DEPLOYED AGAIN. IT STILL DID NOT DEPLOY CIRCUMFERENTIALLY. THE TINES WERE RETRACTED AGAIN WITH DIFFICULTY. THE PHYSICIAN STRUGGLED SIGNIFICANTLY, SO A SECOND NEEDLE WAS SELECTED FOR USE. THE FIRST COAXIAL WAS LEFT IN PLACE, AND THE SAME THING HAPPENED AGAIN. BOTH TIMES WHEN THE PROBE WAS REMOVED, THE TINES WERE NOTED TO BE ASYMMETRICAL AND SKEWED. A THIRD NEEDLE WAS SELECTED FOR USE. THIS TIME, THE FIRST COAXIAL WAS REMOVED AND REPLACED WITH A NEW ONE DESPITE THE PHYSICIAN ACKNOWLEDGING A RISK OF A PNEUMOTHORAX. THE THIRD NEEDLE WAS BENCH TESTED AND THEN INSERTED INTO THE LUNG. THE SAME ISSUES OCCURRED AGAIN. THE DEVICE APPEARED TO BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953594 ↗
• MalfunctionOct 14, 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 KIDNEY CANCER. THE LEVEEN COACCESS WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS IN POSITION IT WAS ATTEMPTED TO BE UNFOLDED. IT WAS REPORTED THAT THE DEVICE DIDN'T OPEN CORRECTLY AND IT STAYED IN A NARROW, TWISTED CONFIGURATION. THIS DEVICE WAS REPLACED WITH ANOTHER ONE, BUT THE SAME ISSUE OCCURRED WITH THE UNFOLDING OF THE DEVICE. 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 10676729 ↗
• MalfunctionOct 14, 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 KIDNEY CANCER. THE LEVEEN CO-ACCESS WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS IN POSITION, IT WAS ATTEMPTED TO BE UNFOLDED. IT WAS REPORTED THAT THE DEVICE DIDN'T OPEN CORRECTLY, AND IT STAYED IN A NARROW, TWISTED, CONFIGURATION. THIS DEVICE WAS REPLACED WITH ANOTHER ONE, BUT THE SAME ISSUE OCCURRED WITH THE UNFOLDING OF THE DEVICE. 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 10676693 ↗
• MalfunctionDec 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TINES BECAME BENT. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH LIVER CANCER. THE LEVEEN COACCESS WAS BEING USED FOR THIS PROCEDURE. WHEN THE PHYSICIAN WAS USING THE DEVICE THE TINES BECAME BENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND 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 9490037 ↗
• MalfunctionAug 27, 2019Failure 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 CANCER. THE LEVEEN COACCESS NEEDLE WAS BEING USED FOR THIS PROCEDURE. THE PHYSICIAN TESTED THE DEVICE PRIOR TO USING AND INSERTING IT INTO THE PATIENT AND FOUND NO ISSUE. WHILE THE DEVICE WAS BEING USE IN THE PATIENT THE PHYSICIAN COULD NOT GET THE PROBE TO FULLY DEPLOY. THIS DEVICE WAS REMOVED FROM THE PATIENT WITH NO OTHER COMPLICATIONS. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936800 ↗
• MalfunctionFeb 14, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE DID NOT DEPLOY PROPERLY. THE LEVEEN COACCESS NEEDLE WAS BEING USED FOR A PROCEDURE. WHEN THE NEEDLE WAS DEPLOYED IT WAS NOTED THAT IT HAD NOT DEPLOYED PROPERLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339529 ↗