Single Use 3-Lumen Extraction Balloon V B-V243Q-A (REF N5384740)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04953170368721), received between Oct 18, 2019 and Mar 11, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE 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 17873053 ↗
• InjuryAug 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE EXTRACTION BALLOON CATHETER BROKE INSIDE THE PATIENT WHILE THE PHYSICIAN ATTEMPTED TO REMOVE STONES. IT WAS REPORTED APPROXIMATELY 30 CM OF CATHETER REMAINED INSIDE THE PATIENT'S COMMON BILE DUCT WHILE THE REMAINING DEVICE WAS PULLED THROUGH THE SCOPE. THE PHYSICIAN USED FOREIGN BODY RETRIEVAL GRASPERS TO REMOVE THE DISTAL PORTION OF THE DEVICE WHICH HAD DISLODGED INSIDE THE PATIENT. THE DEVICE FAILURE WILL REQUIRE A FOLLOW UP ERCP TO REMOVE THE STONES INSIDE THE PATIENT. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15251841 ↗
• InjuryJul 29, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING AN EVIS EXERA III DUODENOSCOPE WITH A SINGLE USE DISTAL COVER AND A SINGLE USE EXTRACTION BALLOON, THE DISTAL COVER SPLIT OPEN DURING THE PROCEDURE AND SEVERAL DEVICES BROKE BECAUSE OF IT. IT WAS OBSERVED THAT BIOBURDEN HAD GOTTEN LODGED BEHIND THE ELEVATOR OF THE SCOPE. THE ELEVATOR COULD NOT FULLY FUNCTION IN ITS RANGE OF MOTION, COULD NOT GO FULLY UP AND DOWN. AT FIRST, THE CUSTOMER NOTICED THAT THE DEVICE (SCOPE/DISTAL COVER) WAS NOT ABLE TO PASS SMOOTHLY THROUGH THE CHANNEL, AND THE PHYSICIAN OBSERVED THAT HE WAS NOT ABLE TO FULLY OPEN OR CLOSE THE ELEVATOR. THE ELEVATOR JAMMED AT 45 DEGREES ANGLE AND WAS NOT ABLE TO FULLY OPEN. WHEN PASSING DEVICES, THE PHYSICIAN ENDED UP STRIPPING AND BREAKING SOME OF THE DEVICES. AN EXTRACTION BALLOON THAT WAS BROKEN UP INSIDE THE PATIENT'S DUCT AND THEY HAD TO TAKE SCOPE OUT AND GO RETRIEVE IT. ONCE RETRIEVED, THE PHYSICIAN TO USE A DIFFERENT BALLOON AND IT STARTED TO BREAK BECAUSE COULD NOT FULLY OPEN ELEVATOR, IT FELT JAMMED. THE PHYSICIAN PLACED A STENT. AFTER BARELY PLACING THE STENT, THEY FINISHED THE PROCEDURE. THE PHYSICIAN TOOK SCOPE OUT AND

  Patient problems: Foreign Body In Patient

  MAUDE report 15128797 ↗
• InjuryJul 29, 2022Break; Material Rupture; Device Damaged by Another Device; Difficult to Advance; Mechanical Jam; Material Split, Cut or Torn

  THE CUSTOMER REPORTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING AN EVIS EXERA III DUODENOSCOPE WITH A SINGLE USE DISTAL COVER AND A SINGLE USE EXTRACTION BALLOON, THE DISTAL COVER SPLIT OPEN DURING THE PROCEDURE AND SEVERAL DEVICES BROKE BECAUSE OF IT. IT WAS OBSERVED THAT BIOBURDEN HAD GOTTEN LODGED BEHIND THE ELEVATOR OF THE SCOPE. THE ELEVATOR COULD NOT FULLY FUNCTION IN ITS RANGE OF MOTION, COULD NOT GO FULLY UP AND DOWN. AT FIRST, THE CUSTOMER NOTICED THAT THE DEVICE (SCOPE/DISTAL COVER) WAS NOT ABLE TO PASS SMOOTHLY THROUGH THE CHANNEL, AND THE PHYSICIAN OBSERVED THAT HE WAS NOT ABLE TO FULLY OPEN OR CLOSE THE ELEVATOR. THE ELEVATOR JAMMED AT 45 DEGREES ANGLE AND WAS NOT ABLE TO FULLY OPEN. WHEN PASSING DEVICES, THE PHYSICIAN ENDED UP STRIPPING AND BREAKING SOME OF THE DEVICES. AN EXTRACTION BALLOON THAT WAS BROKEN UP INSIDE THE PATIENT'S DUCT AND THEY HAD TO TAKE SCOPE OUT AND GO RETRIEVE IT. ONCE RETRIEVED, THE PHYSICIAN TO USE A DIFFERENT BALLOON AND IT STARTED TO BREAK BECAUSE COULD NOT FULLY OPEN ELEVATOR, IT FELT JAMMED. THE PHYSICIAN PLACED A STENT. AFTER BARELY PLACING THE STENT, THEY FINISHED THE PROCEDURE. THE PHYSICIAN TOOK SCOPE OUT AND

  Patient problems: Foreign Body In Patient

  MAUDE report 15128789 ↗
• MalfunctionJul 20, 2020Material Rupture; Material Rupture

  THE USER FACILITY REPORTED THAT A BALLOON POPPED WHEN TRYING TO INFLATE IT DURING A PATIENT PROCEDURE. THERE WAS NO PATIENT INJURY OR HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS FILE 2 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297688 ↗
• MalfunctionJul 20, 2020Material Rupture; Material Rupture

  THE USER FACILITY REPORTED THAT A BALLOON POPPED WHEN TRYING TO INFLATE IT DURING A PATIENT PROCEDURE. THERE WAS NO PATIENT INJURY OR HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS FILE 3 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297659 ↗
• MalfunctionJul 20, 2020Material Rupture; Material Rupture

  THE USER FACILITY REPORTED THAT A BALLOON POPPED WHEN TRYING TO INFLATE IT DURING A PATIENT PROCEDURE. THERE WAS NO PATIENT INJURY OR HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS FILE 1 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296251 ↗
• MalfunctionOct 18, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT DURING AN THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, A TOTAL OF FOUR BALLOONS BROKE IN THE PATIENT. THE BALLOONS USED WERE FROM THREE DIFFERENT LOTS. IT IS UNKNOWN IF ANY DEVICE FRAGMENT FELL INTO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THIS IS 4 OF 4 REPORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9207637 ↗

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 · Terminated
  B-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-0966-2021 · Jan 4, 2021 · Terminated
  B-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-0968-2021 · Jan 4, 2021 · Terminated
  B-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