Single Use 3-Lumen Extraction Balloon V B-V233P-A (UDI 04953170275692)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170275692), received between Oct 13, 2021 and Aug 10, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023Failure to Deflate; Failure to Deflate

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING THE INITIAL CLINICAL USE OF THE DEVICE THE BALLOON ON SINGLE USE 3-LUMEN EXTRACTION BALLOON V WOULD NOT DEFLATE. THE BALLOON WAS PULLED THROUGH THE ENDOSCOPE AND THEN POPPED. THE REPORTED MALFUNCTION WAS FOUND DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17505913 ↗
• InjuryOct 28, 2021Separation Problem; Separation Problem

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION: IT IS UNKNOWN IF THE PATIENT WAS INTENDED TO HAVE THE AUGMENTIN POST-OPERATIVELY OR IF IT WAS ORDERED DUE TO THE UN-RETRIEVED BALLOON. NO POST-OPERATIVE ISSUES WERE DOCUMENTED. IT IS UNKNOWN IF THE SUBJECT DEVICE WAS INSPECTED PRIOR TO USE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THE MALFUNCTION. ON (B)(6) 2021, THE PATIENT RETURNED FOR A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) RECHECK DUE TO THE SUSPECTED RETAINED SMALL PIECE OF BALLOON CATHETER IN BILE DUCT. ADDITIONALLY, THE PATIENT HAD ERCP WITH BILE DUCT STENT REMOVAL, BILE DUCT STONE REMOVAL, BIOPSY OF AMPULLA AND ESOPHAGOGASTRODUODENOSCOPY WITH STOMACH BIOPSY. AN OLYMPUS HD VIDEO DUODENOSCOPE WAS USED FOR THIS PROCEDURE. PROCEDURE AND FINDINGS: EGD: ESOPHAGUS: NORMAL MUCOSA STOMACH: MULTIPLE SMALL ULCERS WITH CLEAN BASE OR PIGMENTED BASE ( LIKELY NSAID INDUCED). RANDOM GASTRIC BIOPSY DONE DUODENUM: NORMAL MUCOSA ERCP FINDINGS: THE DUODENOSCOPE WAS INSERTED INTO THE OROPHARYNX UNDER DIRECT VISUALIZATION AND ADVANCED SMOOTHLY INTO THE STOMACH WHERE THE CONTENTS WERE SUCTIONED. THE SCOPE WAS THEN FURTHER ADVANCED THROUGH A PATENT PYLORUS TO THE SECOND PORTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711579 ↗
• InjuryOct 28, 2021Material Separation

  THIS EVENT WAS REPORTED TO OLYMPUS VIA MEDWATCH REPORT (B)(4). THE PHYSICIAN WAS PERFORMING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), BALLOON SWEEP AND CHOLANGIOSCOPY WITH PERIAMPULLARY BIOPSIES PROCEDURE WHEN THE OLYMPUS DEVICE MALFUNCTIONED. WHILE DOING BALLOON SWEEP OF COMMON BILE DUCT WITH OVER WIRE MULTI-3 V PLUS BALLOON THE ACTUAL BALLOON SEPARATED FROM THE DEVICE AND WAS LEFT INSIDE PAPILLA. AFTER MULTIPLE ATTEMPTS, RETRIEVAL WAS UNSUCCESSFUL AND THE PHYSICIAN PLACED A STENT TO PREVENT CYSTITIS. ERCP FINDINGS/PROCEDURE: THE DUODENOSCOPE WAS INSERTED INTO THE OROPHARYNX UNDER DIRECT VISUALIZATION AND ADVANCED SMOOTHLY INTO THE STOMACH WHERE THE CONTENTS WERE SUCTIONED. A CURSORY VIEW OF THE GASTRIC MUCOSA WAS NORMAL. THE SCOPE WAS THEN FURTHER ADVANCED THROUGH A PENDENT PYLORUS TO THE SECOND PORTION OF THE DUODENUM. THE MAJOR PAPILLA WAS VISUALIZED AND APPEARED SMALL AND FLAT. NO MASS OR GROWTH WAS SEEN. A BILIARY RETRIEVAL BALLOON PRELOADED WITH 0.025 INCH GUIDEWIRE WAS INSERTED INTO THE MAJOR PAPILLA AND WAS ADVANCED INTO THE BILE DUCT AND INTRAHEPATIC DUCTS. OCCLUSION CHOLANGIOGRAM DID NOT SHOW ANY FILLING DEFECT OR STRICTURE. CYSTIC DUCT WAS PATENT. THE BI

  Patient problems: Insufficient Information

  MAUDE report 12711534 ↗
• MalfunctionOct 13, 2021Material Rupture; Material Rupture

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE STONE EXTRACTION BALLOON POPPED. IT POPPED WHEN THE PHYSICIAN INFLATED THE BALLOON WITH THE INFLATION SYRINGE, HE TRIED TO DRAG THE MATERIAL INSIDE THE BILE DUCT. THE PHYSICIAN COULD SEE NO STONES OR BILIARY SLUDGE WAS PRESENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE (UNKNOWN LOT NUMBER. THE CUSTOMER CONFIRMED THERE WERE NO BALLOON FRAGMENTS. THERE WAS PROCEDURAL DELAY WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR 10 MINUTES DUE TO THE BALLOON MALFUNCTION. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625659 ↗

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