Single Use Balloon Dilator V (with knife) BD-VC431Q-1240-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170414107), received between Dec 14, 2023 and Jan 17, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC EST PROCEDURE, IT WAS NOTICED THAT THE EST KNIFE WAS BROKEN BEFORE ENERGIZING. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183580 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SAMPLE PRODUCT OF A BALLOON DILATOR WITH KNIFE WAS USED DURING A BILE DUCT STONE REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. AN UNKNOWN AMOUNT OF TIME LATER, THE PATIENT SUFFERED A BILE DUCT PERFORATION AND EMERGENCY SURGERY WAS PERFORMED. THE CAUSE WAS UNKNOWN. THERE WAS NO REPORTED SERIOUS PROBLEMS FOR THE PATIENT. ACCORDING TO THE SURGEON, IT WAS UNLIKELY THAT THE BALLOON CAUSED THE PERFORATION AS IT WAS INFLATED AT A LOW PRESSURE, BUT IT WAS NOT CLEAR WHAT ROLE THE DEVICE MAY HAVE CONTRIBUTED.

  Patient problems: Internal Organ Perforation

  MAUDE report 19014244 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED, THAT WHEN USING THE BALLOON DILATOR (WITH KNIFE) WHILE TRYING TO PERFORM A NIPPLE INCISION THE KNIFE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE THAT WAS COMPLETED WITH ANOTHER PAPILLOTOMY KNIFE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18643139 ↗
• MalfunctionJan 16, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE BALLOON DILATOR V (WITH KNIFE) WHEN INSERTED INTO THE ENDOSCOPIC FORCEPS CHANNEL TO PERFORM THE THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, HE DISCOVERED A BROKEN KNIFE WIRE ON THE SCREEN AND DID NOT USE IT. THIS WAS BEFORE THE POWER WAS TURNED ON. THE CUSTOMER REPLACED IT WITH ANOTHER SIMILAR PRODUCT TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE KNIFE WIRE WAS DAMAGED, THE COVER WAS PEELED, AND THE KNIFE WIRE EXPOSED. THERE WAS NO HEALTH DAMAGE TO PATIENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515764 ↗
• MalfunctionDec 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE BALLOON DILATOR WAS IN USE FOR A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY. THE CUSTOMER REPORTED THE EXTRACTION BASKET THEY WERE USING BECAME INCARCERATED WITH THE DILATOR. AFTER THAT, THE CUSTOMER CUT THE DILATOR'S SHEATH BUT BASKET WAS STILL INCARCERATED. WHEN USER TRIED TO FORCEFULLY TO INSERT THE PRODUCT THE TIP OF THE KNIFE WIRE BROKE. THE WIRE TIP DID NOT FALL OFF. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE OF THE SAME MODEL NUMBER. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345613 ↗
• MalfunctionDec 14, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE BALLOON DILATOR WITH KNIFE GUIDE WIRE COULD NOT BE PUSHED OUT FROM THE GUIDE WIRE PORT ON THE PROXIMAL SIDE, RESULTING IN THE GUIDE WIRE PROTRUDING ALONG THE SIDE OF THE DEVICE WITHOUT PROTRUDING FROM THE PORT. ADDITIONALLY, THE KNIFE BROKE DURING THE FIRST ENERGIZATION. THE ISSUE WAS FOUND AT THE BEGINNING OF AN ENDOSCOPIC SPHINCTEROTOMY. 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 18327701 ↗