Single Use Balloon Dilator V (with Knife) BD-VC431Q-1840-30Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of Single Use Balloon Dilator V (with knife) (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170373992), received between Sep 22, 2022 and Dec 12, 2023 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2023Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE BALLOON DILATOR V (WITH KNIFE), DURING A SURGICAL PROCEDURE THE ELECTRICITY WAS WEAK AND THE DEVICE WAS LESS SHARP THAN THE DOCTOR EXPECTED. THE ISSUE OCCURRED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE PROCEDURE WAS THERAPEUTIC. THERE ARE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS AND THE EVALUATION FOUND THAT THE COVER WAS PEELED AND THE KNIFE WIRE WAS EXPOSED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18311275 ↗MalfunctionSep 22, 2022Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE BALLOON DILATOR KNIFE WIRE BROKE WHEN THE PHYSICIAN TURNED ON THE ELECTRICITY DURING A DUODENAL PAPILLOTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15464869 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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