Single Use 3-Lumen Extraction Balloon V B-V233P-BRecalls & reported problems
Olympus Medical Systems Corp. · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170368714), received between Jun 19, 2024 and Jun 19, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2024Break; Break
IT WAS REPORTED THAT TWO BALLOONS BROKE AND FELL IN THE PATIENT'S BODY. THE FRAGMENTS WERE SWEPT OUT OF THE DUCT WITH ANOTHER EXTRACTION BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570693 ↗InjuryJun 19, 2024Break; Break
IT WAS REPORTED THAT TWO BALLOONS BROKE AND FELL IN THE PATIENT'S BODY. THE FRAGMENTS WERE SWEPT OUT OF THE DUCT WITH ANOTHER EXTRACTION BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570678 ↗InjuryJun 19, 2024Break; Break
IT WAS REPORTED THAT TWO BALLOONS BROKE AND FELL IN THE PATIENT'S BODY. THE FRAGMENTS WERE SWEPT OUT OF THE DUCT WITH ANOTHER EXTRACTION BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570508 ↗InjuryJun 19, 2024Break; Break
IT WAS REPORTED THAT TWO BALLOONS BROKE AND FELL IN THE PATIENT'S BODY. THE FRAGMENTS WERE SWEPT OUT OF THE DUCT WITH ANOTHER EXTRACTION BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570474 ↗
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-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
- 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
Other DISLODGER, STONE, BILIARY devices
- Memory Basket G25149Cook Incorporated · DISLODGER, STONE, BILIARY75 reports
- Stonetome M00535110Boston Scientific Corporation · DISLODGER, STONE, BILIARY74 reports
- Stonetome M00535150Boston Scientific Corporation · DISLODGER, STONE, BILIARY67 reports
- Cook G36250Cook Incorporated · DISLODGER, STONE, BILIARY1 recall10 reports
- NCompass G36251Cook Incorporated · DISLODGER, STONE, BILIARY1 recall8 reports
- Strange G09108Cook Incorporated · DISLODGER, STONE, BILIARY1 recall1 report
- Single Use Retrieval Nitinol Basket V FG-V451POlympus Medical Systems Corp. · DISLODGER, STONE, BILIARY31 reports
- SpyGlass™ Retrieval Basket M00546550Boston Scientific Corporation · DISLODGER, STONE, BILIARY23 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page