LeVeen™ CoAccess™ M001262240Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729454939), received between Nov 16, 2017 and Mar 3, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionDec 22, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DIFFICULTY TO EXTEND A NEEDLE OCCURRED. A RADIOFREQUENCY ABLATION PROCEDURE WAS PERFORMED ON A LESION LOCATED IN THE LIVER. A 4.0 LEVEEN COACCESS ELECTRODE WAS ADVANCED TO THE LESION, BUT THE DEVICE DID NOT FULLY DEPLOY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

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

  MAUDE report 11055486 ↗
• MalfunctionOct 14, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE TINES OF THE ELECTRODE WERE DIFFICULT TO DEPLOY. A RADIOFREQUENCY ABLATION PROCEDURE OF THE LIVER WAS BEING PERFORMED. A LEVEEN COACCESS ELECTRODE WAS SELECTED FOR USE TO ABLATE THE RENAL TUMOR. IT WAS NOTED THERE WAS A BAD DEPLOYMENT OF THE TINES ON THE ELECTRODE. ANOTHER ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9186834 ↗
• MalfunctionJul 24, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THE TINES OF THE ELECTRODE WERE UNABLE TO EXTEND. A RADIOFREQUENCY ABLATION PROCEDURE OF THE LIVER WAS BEING PERFORMED. A LEVEEN COACCESS ELECTRODE WAS ATTEMPTED TO BE USED, BUT THE TINES OF THE ELECTRODE WOULD NOT EXTEND. THE PHYSICIAN ATTEMPTED THE USE OF STRONG FORCE, BUT WAS STILL UNABLE TO EXTEND THE TINES. ANOTHER ELECTRODE WAS USED TO SUCCESSFULLY ABLATE THE LIVER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821712 ↗
• MalfunctionJun 18, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE PHYSICIAN WASN'T ABLE TO DEPLOY THE DEVICE INSIDE THE RENAL TUMOR. A RADIOFREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A CYSTIC RENAL CELL CARCINOMA TUMOR AND A 3.5CM LEVEEN NEEDLE ELECTRODE WAS INTENDED TO BE USED IN THE PROCEDURE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE INSIDE THE RENAL TUMOR, IT WAS UNABLE TO DEPLOY. THE PHYSICIAN ATTEMPTED A 4CM LEVEEN NEEDLE ELECTRODE, BUT THIS DEVICE DID NOT DEPLOY EITHER. THE PROCEDURE WAS STOPPED AND NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707214 ↗
• MalfunctionFeb 14, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE NEEDLE WAS STUCK. A 4.0/15/15 LEVEEN COACCESS ELECTRODE WAS SELECTED FOR USE IN A RADIOFREQUENCY ABLATION PROCEDURE. PRIOR TO USE A FUNCTIONAL CHECK WAS PERFORMED OUTSIDE THE PATIENT. DURING THE CHECK, THE ELECTRODES DID NOT COME OUT PROPERLY; THEY WERE TWISTED OVER EACH OTHER. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8340975 ↗
• MalfunctionNov 26, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED A DETACHMENT OCCURRED. THE PATIENT WAS UNDERGOING A PULMONARY RADIO FREQUENCY ABLATION PROCEDURE ON AN UNKNOWN DATE. DURING REMOVAL OF THE PROBE, THE DISTAL PORTION (1 CM LONG) REMAINED STUCK TO THE PATIENT'S LUNG. THE PROCEDURE WAS STOPPED AND SURGERY WAS PERFORMED TO REMOVE THE DETACHED PORTION OF THE PROBE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8102046 ↗
• MalfunctionNov 16, 2017Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT INSUFFICIENT ROLL-OFF OCCURRED. THE PATIENT WAS UNDERGOING A RADIOFREQUENCY ABLATION (RFA) TREATMENT. A 4.0/15/15 LEVEEN¿ COACCESS¿ ELECTRODE WAS USED; HOWEVER ROLL-OFF WAS UNABLE TO BE ACHIEVED. THE RIGHT STEPS WERE FOLLOWED AND THE PADS AND NEEDLES WERE PLACED ACCURATELY. THERE WERE NO ERRORS FOUND. WHEN THE PHYSICIAN REMOVED THE NEEDLE FROM THE PATIENT, IT WAS COLD AND THERE WAS NO SIGN OF HEAT. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7037522 ↗