Single Use 3-Lumen Sphincterotome V KD-V411M-0730 (UDI 04953170184055)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 04953170184055), received between Jun 12, 2020 and Aug 18, 2026 — classified as 6 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305533 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME KNIFE WIRE WAS FRACTURED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190875 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME HAD A FRACTURED KNIFE WIRE. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881517 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR.

  Patient problems: Pancreatitis

  MAUDE report 23720510 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE FAILED TO BOW OR CUT, AND THE WIRE EVENTUALLY SNAPPED. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459032 ↗
• MalfunctionJul 21, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V EXHIBITED WIRE BROKEN AND THE PROXIMAL END AND DAMAGED COATED PORTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553826 ↗
• MalfunctionJul 3, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COATED PORTION OF THE CUTTING WIRE ON THE SINGLE-USE 2-LUMEN SPHINCTEROTOME WAS TORN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395254 ↗
• MalfunctionMar 3, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505672 ↗
• MalfunctionFeb 7, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 21339223 ↗
• MalfunctionFeb 7, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 21338821 ↗
• MalfunctionFeb 7, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 21338732 ↗
• MalfunctionFeb 7, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 21338652 ↗
• MalfunctionFeb 7, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 21338239 ↗
• MalfunctionFeb 7, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 21338220 ↗
• MalfunctionFeb 7, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 21337769 ↗
• MalfunctionDec 10, 2024Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894907 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 20854239 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT WHILE USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 20854234 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 20853995 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE CUTTING WIRE OF THE PAPILLOTOME BROKE OR WAS DAMAGED WHEN CUTTING UNDER TENSION. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. 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 20853843 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THE LUMEN SPHINCTEROTOME HAD THE KNIFE WIRE BREAK. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348672 ↗
• MalfunctionSep 17, 2024Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  IT WAS REPORTED THAT THE WIRE OF THE SINGLE-USE 2-LUMEN SPHINCTEROTOME WAS DAMAGED. THE ISSUE OCCURRED DURING A THERAPEUTIC 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 20242654 ↗
• MalfunctionSep 11, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME EXHIBITED COVER PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20196188 ↗
• MalfunctionAug 6, 2024Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE 3-LUMEN SPHINCTEROTOME V EXHIBITED A KNIFE WIRE THAT WAS DAMAGED. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917343 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V'S CUTTING WIRE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM AND THE INTENDED PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680952 ↗