Single Use 3-Lumen Sphincterotome V KD-V411M-0725 (UDI 04953170382635)Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 04953170382635), received between Mar 12, 2019 and Apr 25, 2025 — classified as 1 death, 1 injury, 116 malfunctions.

The most frequently reported specific device problem is “Break” (89 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN FOUND THAT THE KNIFE WIRE HAD FRACTURED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913686 ↗
• MalfunctionMar 12, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE 1-LUMEN SPHINCTEROTOME EXHIBITED SPARKS DUE TO BREAKING OF THE CUTTING WIRE AND THE IS COVERING OF THE KNIFE WIRE WAS PEELED AND DISLODGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585589 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME KNIFE WIRE BROKE DURING A THERAPEUTIC OUTPUT ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20802925 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME KNIFE WIRE BROKE DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION AND THERE WERE NO HEALTH HAZARDS DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384690 ↗
• MalfunctionSep 6, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V EXHIBITED A PEELED COVER AND THE KNIFE WIRE WAS EXPOSED. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158154 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THE KNIFE WIRE BROKE WHILE USING THE SPHINCTEROTOME. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC THORACIC SYMPATHECTOMY (ETS) PROCEDURE. THE KNIFE DID NOT FALL OUT OF THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044682 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT THE SPHINCTEROTOME V EXHIBITED A BROKEN WIRE. THE EVENT OCCURRED DURING AN UNKNOWN PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19648154 ↗
• MalfunctionJun 3, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE 2-LUMEN SPHINCTEROTOME INSULATION COVER OF THE KNIFE WIRE WAS PEELED OFF. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448116 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME KNIFE WIRE WAS FOUND BROKEN (BEFORE BEING INSERTED INTO THE BODY/BEFORE ELECTRICITY WAS APPLIED). THE ISSUE WAS FOUND DURING ENDOSCOPIC SPHINCTEROTOMY PROCEDURE THAT COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446129 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED THE KNIFE OF THE SINGLE USE 2-LUMEN SPHINCTEROTOME WAS BROKEN AFTER AN ELECTRICAL CURRENT ERROR OCCURRED DURING THE SECOND INCISION. THE ISSUE OCCURRED DURING A THERAPEUTIC EST (ENDOSCOPIC SPHINCTEROTOMY) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237165 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME V EXHIBITED THE WIRE BROKE DURING OUTPUT. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227108 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 2-LUMEN SPHINCTEROTOME KNIFE WIRE WAS FOUND TO BE BROKEN. THE ISSUE OCCURRED DURING INSPECTION BEFORE STARTING THE ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE DEVICE WITH ANOTHER OF THE SAME TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193238 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 3-LUMEN SPHINCTEROTOME KNIFE WIRE WAS DAMAGED. THE ISSUE OCCURRED DURING THE THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE WITH NO REPORTS OF DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169842 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT THE KNIFE OF THE SINGLE USE LUMEN SPHINCTEROTOME BROKE WHEN ELECTRICITY WAS APPLIED. THE CUSTOMER STATED THAT IT WAS LIKELY CAUSED BY A STONE NEAR THE NIPPLE. THE ISSUE OCCURRED DURING THE THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY, AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19148983 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT THE KNIFE WIRE HAD BROKEN WHEN ELECTRICITY WAS APPLIED, WHILE USING THE ENDO THER, EN DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102128 ↗
• MalfunctionMar 13, 2024Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING THERAPEUTIC ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY), WHEN THE SPHINCTEROTOME WAS OUTPUTTING HIGH FREQUENCY SIGNALS, THE WIRE BROKE ON THE FIRST PRESS. THE USER REPLACED THE DEVICE WITH A SIMILAR PRODUCT AND COMPLETED THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899134 ↗
• MalfunctionMar 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE KNIFE TIP COATING OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS PEELED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. NO PARTS FELL INTO THE PATIENT'S BODY. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845973 ↗
• MalfunctionMar 4, 2024Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING THERAPEUTIC ENDOSCOPIC PAPILLARY SPHINCTEROTOMY, THE SPHINCTEROTOME WAS ENERGIZED SEVERAL TIMES AND THE KNIFE WIRE SNAPPED WHILE CUTTING THE TISSUE. THE OUTPUT SETTINGS WERE UNKNOWN, ALTHOUGH IT WAS NOTED THAT THE SETTINGS HAD NOT CHANGED FROM PREVIOUS SETTINGS. NO SHEDDING INSIDE THE BODY. THERE WAS NO BLEEDING DUE TO ANY MALFUNCTION. THE DOCTOR REPLACED IT WITH ANOTHER PRODUCT WITH THE SAME MODEL NUMBER AND COMPLETED THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833460 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 2-LUMEN SPHINCTEROTOME HAD A BROKEN KNIFE WIRE WHEN THE POWER WAS TURNED ON. THERE WAS NO INTERNAL SHEDDING. THE ISSUE OCCURRED DURING A THERAPEUTIC PAPILLOTOMY OF THE DUODENUM PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778953 ↗
• MalfunctionFeb 12, 2024Break; Break

  IT WAS REPORTED, THE SPHINCTEROTOME'S KNIFE WIRE BROKE WHEN ELECTRICITY WAS APPLIED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686429 ↗
• MalfunctionFeb 12, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE KNIFE COULD NOT CUT DUE TO A DEFECT IN THE INSULATION COATING OF THE SPHINCTEROTOME. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY THAT WAS COMPLETED BY USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684656 ↗
• MalfunctionFeb 9, 2024Break; Melted; Break; Melted

  IT WAS REPORTED, THE KNIFE WIRE OF LUMEN SPHINCTEROTOME V WAS NOT FACING THE 11 O'CLOCK DIRECTION. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE(ENDOSCOPIC SPHINCTEROTOMY). THE INTENDED PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676747 ↗
• MalfunctionFeb 2, 2024Break; Melted; Break; Melted

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WAS BROKEN DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SURGERY PROCEDURE. THE KNIFE WIRE WAS BROKEN AT THE SECOND CUT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTED DELAYS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629121 ↗
• MalfunctionJan 31, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THE KNIFE WAS CUT OFF WHEN AN ATTEMPT WAS MADE TO ENERGIZE THE SPHINCTEROTOME. THE ISSUE OCCURRED DURING PROCEDURE. THE PROCEDURE WAS FOR A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617465 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) PROCEDURE, AFTER INSERTING THE SPHINCTEROTOME INTO THE DUODENAL PAPILLA, A KNIFE WAS STRUNG UP AND ELECTRICITY WAS APPLIED SEVERAL TIMES, BUT THE KNIFE WAS NOT CUT WELL AND THE KNIFE WIRE BROKE AFTER THE FIRST FEW TIMES. THE DOCTOR REPLACED IT WITH ANOTHER IDENTICAL PRODUCT AND COMPLETED THE PROCEDURE WITHOUT ANY FALLING OUT OF THE BODY. THE PATIENT WAS HOSPITALIZED AFTER THE PROCEDURE AS PLANNED. THE STATUS OF THE PATIENT WAS GOOD. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591972 ↗