Single Use Balloon Dilator V (with knife) BD-VC431Q-1240-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170414084), received between Nov 11, 2021 and Apr 23, 2025 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT WHILE USING THE BALLOON DILATOR, THE DOCTOR TRIED TO DILATE A BALLOON AND IT POPPED. THE EVENT OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ECRP) WITH STONE EXTRACTION AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT WAS UNDER SEDATION AND THERE WAS A FIFTEEN MINUTE DELAY BUT THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894466 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED WHILE THE PATIENT WAS UNDER SEDATION FOR A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE USER WAS USING THE CUTTING WIRE TO CUT THE PAPILLA AND THE CUTTING WIRE PERFORATED THE PATIENT'S BILE DUCT. THE PROCEDURE ENDED ONCE THE PERFORATION OCCURRED AND THE PATIENT WAS TAKEN TO ANOTHER ROOM TO ADDRESS THE PERFORATION.

  Patient problems: Internal Organ Perforation

  MAUDE report 21579946 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED WHILE THE PATIENT WAS UNDER SEDATION FOR A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE USER WAS USING THE CUTTING WIRE TO CUT THE PAPILLA AND THE CUTTING WIRE PERFORATED THE PATIENT'S BILE DUCT. THE PROCEDURE ENDED ONCE THE PERFORATION OCCURRED AND THE PATIENT WAS TAKEN TO ANOTHER ROOM TO ADDRESS THE PERFORATION.

  Patient problems: Internal Organ Perforation

  MAUDE report 21579517 ↗
• DeathNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING NEWSPAPER ARTICLE TITLED, "A WOMAN DIED SUDDENLY TWO DAYS AFTER AN ENDOSCOPY, PERFORMED BY A PROFESSOR AT (B)(6) HOSPITAL...EXTERNAL INVESTIGATION: ¿POSSIBILITY OF BILE DUCT DAMAGE¿.". IN 2021, A WOMAN DIED SUDDENLY TWO DAYS AFTER UNDERGOING AN ENDOSCOPY PROCEDURE AT (B)(6) HOSPITAL. THE PROCEDURE, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WAS PERFORMED TO EXAMINE HER BILE DUCTS DUE TO ABNORMAL LIVER AND BILE DUCT TEST RESULTS. ALTHOUGH THE ERCP SHOWED NO SIGNIFICANT ABNORMALITIES, THE PROFESSOR CONDUCTING THE PROCEDURE PERFORMED AN ADDITIONAL CHOLANGIOSCOPY TO DIRECTLY EXAMINE THE BILE DUCTS, USING A BALLOON TO DILATE THE BILE DUCT ENTRANCE. ABOUT 10 HOURS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND DIED ON THE NIGHT OF THE (B)(6). NO CHOLANGITIS WAS FOUND, AND THE DEATH CERTIFICATE STATED THAT THE CAUSE OF DEATH WAS ¿ACUTE PANCREATITIS.". A GOVERNMENT MEDICAL INVESTIGATION CONCLUDED THAT THE PROCEDURE WAS LIKELY POORLY EXECUTED AND THAT BILE DUCT DAMAGE COULD HAVE CONTRIBUTED TO HER DEATH. SPECIFICALLY, THE REPORT SUGGESTED THAT BECAUSE THE PATIENT'S BILE DUCTS WERE NARROW, EXCESSIVE PRESSURE FROM THE BALLOON DI

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiac Arrest; Decreased Level of Consciousness; Dehydration; Hyperkalemia; Pancreatitis; Renal Failure; Respiratory Arrest

  MAUDE report 20696195 ↗
• MalfunctionDec 27, 2023Break; Break

  THE KNIFE WIRE BROKE WHEN ELECTRICITY WAS APPLIED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE OPERATION AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401070 ↗
• MalfunctionJul 14, 2023Break; Break

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER DURING A THERAPEUTIC ENDOSCOPIC PAPILLOTOMY, THE KNIFE BROKE WHEN TRYING TO INCISE THE NIPPLE WITH A SINGLE USE BALLOON DILATOR V (WITH KNIFE). THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330137 ↗
• MalfunctionNov 11, 2021Break; Break

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, THE WIRE OF THE DEVICE KNIFE BROKE. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796095 ↗