Single Use 3-Lumen Extraction Balloon V B-V443Q-A (UDI 04953170279553)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170279553), received between Jan 9, 2020 and Jan 9, 2020 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2020Break; Deflation Problem; Break; Deflation Problem

  THE SERVICE CENTER RECEIVED A REPORT OF A SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL B-V443Q-A, LOT NUMBER 92 V27, THAT WOULD NOT DEFLATE AND CAUSED A CATHETER TO BREAK AT THE END OF A PROCEDURE. THE BALLOON AND CATHETER WERE INSPECTED PRIOR TO THE PROCEDURE AND OBSERVED TO HAVE NO ANOMALIES. IT WAS REPORTED THE PHYSICIAN HAD COMPLETED A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WHEN IN THE PROCESS OF REMOVING THE BALLOON, IT WOULD NOT DELATE AND CAUSED THE CATHETER TO BREAK INTO TWO PIECES INSIDE THE PATIENT. THE BALLOON AND CATHETER PIECES WERE RETRIEVED BY THE PHYSICIAN USING A SNARE WITHOUT INJURY TO THE PATIENT. THE PATIENT WAS DISCHARGED THE SAME DAY. THE BALLOON WAS STILL INFLATED WHEN IT WAS RETRIEVED AND HAD NO HOLES OR ANY DAMAGES THAT WERE VISUALLY OBSERVED. IT WAS REPORTED THAT THE BALLOON WAS INFLATED AS INSTRUCTED TO 15 MM, WITHOUT LUBRICATION, USING THE PREMEASURED SYRINGES INCLUDED IN THE PACKAGE. THE MAXIMUM READING ON THE SYRINGE IS 15 MM. IT IS UNKNOWN IF THE STOPCOCK WAS ROTATED 90 DEGREES COUNTERCLOCKWISE TO OPEN AND REMOVE THE SYRINGE, TO DEFLATE THE BALLOON. FLUOROSCOPY/ X-RAY WAS USED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571934 ↗

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-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