Single Use 3-Lumen Extraction Balloon V B-V231P-ARecalls & reported problems
Olympus Medical Systems Corp. · Single Use 3-Lumen Extraction Balloon V · Class 2
All models of Single Use 3-Lumen Extraction Balloon V (9)
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 04953170183430), received between Jul 22, 2022 and Jul 22, 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
- Pancreatitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED IN THE LITERATURE TITLED ¿APPLICATION AND USEFULNESS OF A NEW EIGHT-WIRE BASKET CATHETER FOR ENDOSCOPIC EXTRACTION OF SMALL COMMON BILE DUCT STONES: A RETROSPECTIVE MULTICENTER STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER PROCEDURES USING MULTIPLE OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS JF-260V. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-Q290V. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS B-V231P-A. OBJECTIVES: DISTALLY LOCATED SMALL COMMON BILE DUCT STONES ARE OFTEN DIFFICULT TO TREAT OR GRASP ENDOSCOPICALLY. THEREFORE, MULTIPLE DEVICES, SUCH AS BASKETS OR BALLOON CATHETERS, ARE FREQUENTLY USED IN SUCH CASES. HOWEVER, ITIS DESIRABLE TO USE A SINGLE DEVICE FOR STONE EXTRACTION FROM THE PERSPECTIVE OF COST-EFFECTIVENESS. IN THIS MULTICENTER STUDY, WE EVALUATED THE EFFICACY OF A NEW EIGHT-WIRE BASKET CATHETER FOR EXTRACTING SMALL (=10 MM) COMMON BILE DUCT STONES. METHODS: WE RETROSPECTIVELY ANALYZED THE RECORDS OF 144 PATIENTS WHO UNDERWENT STONE EXTRACTION USING THE EIGHT-WIRE BASKET CATHETER FOR COMMON BILE DUCT STONES=10 MM. THE SUCCESS RATE OF COMPLETE STONE EXTRACTION AND THE RISK FACTORS FOR THE DIFFICULTY IN STONE EXTRACTION WITH TH
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis
MAUDE report 15086304 ↗
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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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