Single Use 3-Lumen Extraction Balloon V B-V233P-A (REF N5384540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170368707), received between Sep 24, 2021 and May 21, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, 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 ↗
• 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 ↗
• InjurySep 24, 2021Break

  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. PHYSICIAN DECIDED TO PLACE STENT TO PROTECT AGAINST CYSTITIS. PROCEDURAL NOTE: INDICATIONS FOR PROCEDURE:¿PATIENT IS STATUS POST AMPULLARY ADENOMA RESECTION IN (B)(6) 2020¿(ENDOSCOPIC AND ALSO WITH APC AND RFA FOR RESIDUAL TISSUE). SHE HAS BEEN ON SURVEILLANCE SINCE THEN. ¿PREVIOUS BIOPSIES HAVE BEEN NEGATIVE FOR ANY RESIDUAL DISEASE.¿¿SHE IS HERE FOR¿ERCP WITH PERIAMPULLARY BIOPSIES. PROCEDURE(S) PERFORMED: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)¿, BALLOON SWEEPS. CHOLANGIOSCOPY. ERCP¿FINDINGS: 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 PATENT 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 IN TO TH

  Patient problems: Foreign Body In Patient

  MAUDE report 12525329 ↗

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 · 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
• 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