Single Use Balloon Dilator V (with Knife) BD-VC431Q-1840-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170373954), received between Sep 12, 2022 and Jun 28, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionJun 28, 2024Break; Break

  THE CUSTOMER REPORTED THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE, HIS OLYMPUS SINGLE-USE BALLOON DILATOR KNIFE BROKEN. ACCORDING TO THE INITIAL REPORTER, THE SEGMENTED PORTION DID NOT FALL OUT OF THE BODY. REPORTEDLY, THE PROCEDURE WAS COMPLETED, WITHOUT PATIENT HARM, AFTER REPLACING THE DAMAGED DEVICE WITH A SIMILAR ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633205 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "EFFICACY OF ENDOSCOPIC LARGE BALLOON DILATION EXTENDED FOR¿¿¿2 MINUTES IN BILE DUCT STONE REMOVAL A MULTICENTER RETROSPECTIVE STUDY," PATIENTS EXPERIENCED ADVERSE EVENTS DURING/AFTER ENDOSCOPIC PAPILLARY LARGE BALLOON DILATION PROCEDURES USING STONEMASTERV LARGE DILATION BALLOONS. BACKGROUND/PURPOSE. THERE IS NO EVIDENCE REGARDING THE OPTIMAL BALLOON DILATION TIME DURING ENDOSCOPIC PAPILLARY LARGE BALLOON DILATION (EPLBD). THE STUDY AIM WAS TO EVALUATE THE EFFICACY OF 2-MINUTE EXTENDED BALLOON DILATION FOR EPLBD. METHODS. TWO HUNDRED AND FIVE PATIENTS WHO UNDERWENT EPLBD DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR BILE DUCT STONES AT THREE TERTIARY CENTERS WERE INCLUDED IN THE ANALYSIS. CLINICAL OUTCOMES AND THE ADVERSE EVENTS WERE COMPARED BETWEEN THE 0-MINUTE GROUP (N = 94, BALLOON DEFLATED IMMEDIATELY AFTER WAIST DISAPPEARANCE) AND THE 2-MINUTE GROUP (N = 111, BALLOON DILATION MAINTAINED FOR 2 MINUTES AFTER WAIST DISAPPEARANCE). THE RISK FACTORS OF POST-ERCP PANCREATITIS (PEP) AFTER EPLBD WERE ASSESSED. RESULTS. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE STONE REMOVAL RATES AND HOSPITALIZATION PERIODS BETWEEN THE TW

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 15674226 ↗
• MalfunctionSep 12, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE KNIFE ON HIS OLYMPUS SINGLE-USE BALLOON DILATOR V (WITH KNIFE) SEPARATED DURING THERAPEUTIC PAPILLOTOMY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE KNIFE BROKEN WHEN THE PAPILLARY INCISION WAS MADE. HOWEVER, THE DAMAGED PART DID NOT FALL OFF. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITH NO HARM TO THE PATIENT. THIS INITIAL REPORTER DID NOTE THAT THE PHYSICIAN USED A DIFFERENT THAN USUAL TECHNIQUE WHEN INSERTING THE KNIFE BUT DID NOT SPECIFIC HOW IT WAS DIFFERENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401778 ↗