Single Use 3-Lumen Extraction Balloon V B-V243Q-A (UDI 04953170279515)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170279515), received between Dec 11, 2019 and Dec 12, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BALLOON BURST WHEN TRYING TO WITHDRAW IT FROM THE PANCREATIC DUCT. THE BALLOON WAS REMOVED FROM THE PATIENT AND WAS INTACT UPON RETRIEVED. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9459379 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BALLOON BURST WHEN TRYING TO WITHDRAW IT FROM THE PANCREATIC DUCT. THE BALLOON WAS REMOVED FROM THE PATIENT AND WAS INTACT UPON REMOVAL. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9452610 ↗

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