Single Use 3-Lumen Sphincterotome V KD-V431M-0720 (REF N1090430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170184178), received between May 18, 2022 and Dec 20, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 7, 2026Class IIOpen, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1275-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2023Break; Break

  THE CUSTOMER REPORTED THE SPHINCTEROTOME WAS IN USE FOR A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY. THE DEVICE'S KNIFE WIRE BROKE WHEN ELECTRICITY WAS APPLIED. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH ANOTHER ONE. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367592 ↗
• MalfunctionMar 28, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST), THE TIP KNIFE WIRE OF THEIR SINGLE USE 3-LUMEN SPHINCTEROTOME V BROKE, CAUSING SPARKS TO OCCUR. NO DEBRIS FELL OFF, AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633010 ↗
• MalfunctionMay 18, 2022Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME V WIRE BROKE WHEN THE PAPILLA WAS INCISED. THE EVENT OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE AND A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427695 ↗