Single Use Biliary Balloon Dilator BD-210N-0420Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Biliary Balloon Dilator · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170399985), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Inflammation1
- Pancreatitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITERATURE SUMMARY: THE AIM OF THE RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFECTS OF ENDOSCOPIC TREATMENT IN PATIENTS WITH SECONDARY SCLEROSING CHOLANGITIS (SSC), THE OUTCOME OF THIS DISORDER, AND ASSOCIATION WITH POTENTIAL RISK FACTOR. THERE WERE 80 PATIENTS WITH SSC INCLUDED IN THE STUDY. SEVENTY-FIVE PATIENTS (93.8%) UNDERWENT DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY; 46 PATIENTS (57.5%) COULD BE TREATED ENDOSCOPICALLY. TRANSPLANTATION-FREE SURVIVAL WAS AFFECTED NEITHER BY ENDOSCOPIC TREATMENT NOR BY PRESENCE OF BILIARY STRICTURES, BUT BACTERIA POSITIVE BILE CULTURE WAS ASSOCIATED WITH BETTER AND INCREASED LEVELS OF SERUM ALKALINE PHOSPHATASE AND BILIRUBIN LEVELS WITH POOR OUTCOME. THIS STUDY CONCLUDED THAT SECONDARY SCLEROSING CHOLANGITIS IS A PROGRESSIVE DISEASE WITH POOR LONG-TERM PROGNOSIS. ENDOSCOPIC TREATMENT OPTIONS SEEM TO BE LIMITED REGARDING TRANSPLANTATION-FREE SURVIVAL BUT MIGHT IMPROVE QUALITY OF LIFE AND PREVENT LOCAL COMPLICATIONS SUCH AS CHOLANGITIS. THE ASSOCIATED TYPES OF ADVERSE EVENTS / NUMBER OF PATIENTS REPORTED IN THE LITERATURE: DEATH - 27 PATIENTS PROCEDURE-RELATED COMPLICATIONS: CHOLANGITIS - 8 PATIENTS POST-ERCP PANCREATITIS - 2 PATIENTS BLEED
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pancreatitis
MAUDE report 15929491 ↗
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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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