Single Use Balloon Dilator V (with Knife)Recalls & reported problems across all models

We found 6 models of Single Use Balloon Dilator V (with Knife) by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2021 and Apr 23, 2025 — classified as 1 death, 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Single Use Balloon Dilator V (with Knife) problems

Single Use Balloon Dilator V (with Knife) models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Balloon Dilator V (with knife) BD-VC431Q-1240-20

  Stents, drains and dilators for the biliary ducts
  1 death7 reports
• Single Use Balloon Dilator V (with knife) BD-VC431Q-1240-25

  Unit, electrosurgical, endoscopic (with or without accessories)
  6 reports
• Single Use Balloon Dilator V (with Knife) BD-VC431Q-1840-25

  CATHETER, BILIARY, DIAGNOSTIC
  4 reports
• Single Use Balloon Dilator V (with Knife) BD-VC431Q-1840-20

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 reports
• Single Use Balloon Dilator V (with Knife) BD-VC431Q-1840-30

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• Single Use Balloon Dilator V (with knife) BD-VC431Q-1240-30

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 report

Recent Single Use Balloon Dilator V (with Knife) adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿PROPHYLACTIC USE OF A SELF-ASSEMBLING PEPTIDE HYDROGEL FOR PREVENTING DELAYED BLEEDING AFTER ENDOSCOPIC SPHINCTEROTOMY: A PROPENSITY SCORE-MATCHED ANALYSIS." BACKGROUND AND AIM: DELAYED ENDOSCOPIC SPHINCTEROTOMY-RELATED BLEEDING (ES BLEEDING) IS AN UNAVOIDABLE ADVERSE EVENT (AE) THAT CAN HAVE SERIOUS RAMIFICATIONS. INTRAOPERATIVE ES BLEEDING, WHICH STOPS SPONTANEOUSLY IN MOST CASES, IS A KNOWN RISK FACTOR FOR DELAYED BLEEDING. THIS STUDY AIMED TO EXAMINE THE PREVENTIVE EFFECT OF A NOVEL SELF-ASSEMBLING PEPTIDE (SAP) FOR DELAYED ES BLEEDING IN PATIENTS WHO ATTAINED SPONTANEOUS HEMOSTASIS AFTER INTRAOPERATIVE ES BLEEDING. METHODS: A TOTAL OF 1507 PATIENTS MET THE ELIGIBILITY CRITERIA FOR INCLUSION IN THIS STUDY. THE RATES OF DELAYED ES BLEEDING AND AE BESIDES BLEEDING WERE COMPARED BETWEEN PATIENTS ADMINISTERED THE SAP (SAP GROUP) AND THOSE WHO WERE SIMPLY OBSERVED AFTER SPONTANEOUS HEMOSTASIS OF INTRAOPERATIVE ES BLEEDING (CONTROL GROUP). PROPENSITY SCORE MATCHING WAS PERFORMED TO ADJUST FOR DIFFERENCES BETWEEN THE GROUPS. RESULTS: THE RATE OF DELAYED ES BLEEDING WAS SIGNIFICANTLY LOWER IN THE SAP GROUP THAN THAT IN THE CONTROL GROUP

  Patient problems: Aspiration Pneumonitis; Cholangitis; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation

  MAUDE report 20839505 ↗
• 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 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THE KNIFE OF THE BALLOON DILATOR BROKE WHEN ELECTRICITY WAS APPLIED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. 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 19906922 ↗
• 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 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED, THE BALLOON DILATOR V THE KNIFE BROKE AFTER INSERTING THE ENDOSCOPE. THE ISSUE OCCURRED DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080236 ↗
• 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 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, THE BALLOON DILATOR V WITH KNIFE THE COVER WAS PEELED AND THE KNIFE WIRE WAS EXPOSED. THE ISSUE OCCURRED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765062 ↗
• 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 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 ↗
• 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 ↗

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