Single Use 3-Lumen Extraction Balloon V B-V433P-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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170275746), received between Dec 10, 2020 and Dec 10, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K091495); they may or may not involve this specific model.
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
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2020Material Separation; Material Separation
AN OLYMPUS SALES REPRESENTATIVE REPORTED THAT A BALLOON RUPTURED DURING A PROCEDURE AND THE PHYSICIAN HAD TO EXTRACT THE BALLOON. THE EVENT OCCURRED DURING THE INITIAL USE OF THE DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10987270 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091495. One submission often covers many models, so check the product and lot details in each record.
- Z-0967-2021 · Jan 4, 2021 · TerminatedB-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct s
- Z-0968-2021 · Jan 4, 2021 · TerminatedB-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct s
- Z-0966-2021 · Jan 4, 2021 · TerminatedB-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct s
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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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