Single Use 3-Lumen Extraction Balloon VRecalls & reported problems across all models
Olympus Medical Systems Corp. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 9 models of Single Use 3-Lumen Extraction Balloon V by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Oct 18, 2019 and May 21, 2026 — classified as 15 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Break” (16 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Single Use 3-Lumen Extraction Balloon V problems
Device problems
- Break16
- Material Rupture7
- Failure to Deflate4
- Deflation Problem3
- Detachment of Device or Device Component3
- Material Separation2
- Material Split, Cut or Torn2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient5
- Foreign Body In Patient4
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Pancreatitis1
Single Use 3-Lumen Extraction Balloon V models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use 3-Lumen Extraction Balloon V B-V243Q-ACATHETER, BILIARY, DIAGNOSTIC15 reports
- Single Use 3-Lumen Extraction Balloon V B-V233P-ACATHETER, BILIARY, DIAGNOSTIC5 reports
- Single Use 3-Lumen Extraction Balloon V B-V233P-ADISLODGER, STONE, BILIARY4 reports
- Single Use 3-Lumen Extraction Balloon V B-V233P-BDISLODGER, STONE, BILIARY4 reports
- Single Use 3-Lumen Extraction Balloon V B-V443Q-ACATHETER, BILIARY, DIAGNOSTIC4 reports
- Single Use 3-Lumen Extraction Balloon V B-V243Q-ACATHETER, BILIARY, DIAGNOSTIC2 reports
- Single Use 3-Lumen Extraction Balloon V B-V231P-ACATHETER, BILIARY, DIAGNOSTIC1 report
- Single Use 3-Lumen Extraction Balloon V B-V433P-ACATHETER, BILIARY, DIAGNOSTIC1 report
- Single Use 3-Lumen Extraction Balloon V B-V443Q-ADISLODGER, STONE, BILIARY1 report
Recent Single Use 3-Lumen Extraction Balloon V adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Failure to Deflate
IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE SINGLE USE 3-LUMEN EXTRACTION BALLOON WOULD NOT DEFLATE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240470 ↗MalfunctionMar 11, 2026Deflation Problem
IT WAS REPORTED THAT THE SINGLE USE 3 LUMEN EXTRACTION BALLOON GOT STUCK AND WAS DIFFICULT TO REMOVE. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PROCEDURE WAS COMPLETED, AFTER A DELAY, USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24568060 ↗MalfunctionSep 5, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE BILIARY EXTRACTION BALLOON BROKE AND SEPARATED INSIDE THE PATIENT WHEREIN THE WIRE CAME OUT SHORT. THE METALLIC PIECE WAS SEPARATED, AND THE BALLOON WAS INFLATED ABOVE A STONE. WHEN SWEEPING, THE PHYSICIAN LOST THE TENSION AND REALIZED THERE WAS NO COUPLING OF MOVEMENTS. THE ISSUE OCCURRED DURING A THERAPEUTIC (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) ERCP PROCEDURE THAT WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22986729 ↗MalfunctionNov 13, 2024
INSERTED VIA ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SCOPE INTO COMMON BILE DUCT, SCRUB TECH ATTEMPTED TO INFLATE BALLOON WITH PROVIDED INFLATION SYRINGE, BALLOON WOULD NOT COMPLETELY INFLATE OR STAY INFLATED. REMOVED BALLOON OUT OF SCOPE BALLOON INFLATED WITH PROVIDED INFLATION SYRINGE, AND ENDOSCOPIST NOTICED LEAK IN THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20673826 ↗MalfunctionNov 5, 2024
BALLOON DID NOT INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609564 ↗MalfunctionNov 5, 2024
INSERTED EXTRACTION BALLOON TO SWEEP BILE DUCT AND BALLOON DID NOT WORK, IT HAD A HOLE UPON INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609518 ↗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 ↗MalfunctionJun 5, 2024Failure to Deflate; Failure to Deflate
IT WAS REPORTED, THE SINGLE USE 3-LUMEN EXTRACTION BALLOON WOULD NOT DEFLATE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY¿PROCEDURE WHICH WAS COMPLETED USING SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19468024 ↗MalfunctionJun 4, 2024Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE WHEN USED WITH THE SYRINGE. ANOTHER SYRINGE WAS USE AND THE BALLOON STILL DID NOT DEFLATE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO SWEEP THE BILE DUCT FOR SLUDGE AND STONES. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459577 ↗InjuryApr 19, 2024Material Rupture; Material Rupture
IT WAS REPORTED THE SINGLE USE 3-LUMEN EXTRACTION BALLOON POPPED INSIDE THE PATIENT DURING AN UNSPECIFIED PROCEDURE. EARS, NOSE, THROAT (ENT) NEEDED TO RE-INTERVENE/RETRIEVE THE BALLOON FRAGMENTS LEFT BEHIND IN THE PATIENT. ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND DEVICE RETRIEVAL WAS REQUESTED, BUT NOT PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19144698 ↗InjuryApr 19, 2024Material Rupture; Material Rupture
IT WAS REPORTED THE SINGLE USE 3-LUMEN EXTRACTION BALLOON POPPED INSIDE THE PATIENT DURING AN UNSPECIFIED PROCEDURE. EARS, NOSE, THROAT (ENT) NEEDED TO RE-INTERVENE/RETRIEVE THE BALLOON FRAGMENTS LEFT BEHIND IN THE PATIENT. ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND DEVICE RETRIEVAL WAS REQUESTED, BUT NOT PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19144686 ↗InjuryOct 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, A SINGLE USE 3-LUMEN EXTRACTION BALLOON V, SPLIT IN HALF DURING A RETRIEVAL SWEEP. THE EXTRACTION BALLOON BROKE IN HALF AT THE PROXIMAL SHORT WIRE INSERTION PORT. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY- ERCP) AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PROCEDURAL DELAY, OR NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17873060 ↗
Other Olympus Medical Systems Corp. products
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- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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