Single Use 3-Lumen Extraction Balloon V B-V443Q-A (REF N5385140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170368769), received between Oct 18, 2019 and May 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN EXTRACTION BALLOON V BALLOON WILL NOT DEFLATE. THE EVENT WAS DISCOVERED DURING A PROCEDURE, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971018 ↗
• 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 2 OF 4 REPORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9207661 ↗
• 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 1 OF 4 REPORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9207624 ↗
• 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 3 OF 4 REPORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9207615 ↗

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-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-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