BALLOON3 MAJ-233 (UDI 04953170058783)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170058783), received between Sep 21, 2023 and Sep 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

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 16, 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.

• MalfunctionSep 26, 2023Separation Failure; Separation Failure

  A CUSTOMER SUBMITTED A MEDSUN REPORT TO FDA (UNITED STATES FOOD AND DRUG ADMINISTRATION) STATING, THE REMNANT OF A BALLOON WAS LEFT BEHIND ON A SCOPE AFTER AN ENDOSCOPIC ULTRASOUND AND WENT THROUGH THE HIGH-LEVEL DISINFECTION PROCESS. IT IS NOT CLEAR IF THE BALLOON WAS NOT FULLY REMOVED PRIOR TO REPROCESSING OR IT BROKE, LEAVING THE ELASTIC BAND BEHIND. THIS WENT UNNOTICED DUE TO THE COLOR OF THE BALLOON BEING A SIMILAR COLOR TO THAT OF THE SCOPE. A NEW BALLOON WAS THEN APPLIED OVER THE REMNANT AND UTILIZED ON A SECOND PATIENT. THIS PLACED THE PATIENT AT RISK OF POTENTIALLY BEING EXPOSED TO A BLOODBORNE PATHOGEN. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THERE IS A REQUEST TO CONSIDER MANUFACTURING BALLOONS IN A DIFFERENT COLOR OTHER THAN OFF-WHITE, TO ENSURE THE BALLOON IS EASILY IDENTIFIABLE. THERE WERE NO ALERTS WHEN THE SUBJECT DEVICE WAS GOING THROUGH THE HIGH-LEVEL DISINFECTION PROCESS. THE REMNANT WAS NOT IDENTIFIED UNTIL AFTER THE PROCEDURE WAS COMPLETED. THE INTENDED PROCEDURE WAS A DIAGNOSTIC ENDOSCOPIC ULTRASOUND WITH BIOPSY. THE PATIENT WAS OFFERED LAB MONITORING FOR COMMUNICABLE AGENTS SUCH AS HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND HEPATITIS (HEP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822222 ↗
• MalfunctionSep 21, 2023Separation Failure; Separation Failure

  A CUSTOMER SUBMITTED A MEDSUN REPORT TO FDA (UNITED STATES FOOD AND DRUG ADMINISTRATION) STATING, THE REMNANT OF A BALLOON WAS LEFT BEHIND ON A SCOPE AFTER AN ENDOSCOPIC ULTRASOUND AND WENT THROUGH THE HIGH-LEVEL DISINFECTION PROCESS. IT IS NOT CLEAR IF THE BALLOON WAS NOT FULLY REMOVED PRIOR TO REPROCESSING OR IT BROKE, LEAVING THE ELASTIC BAND BEHIND. THIS WENT UNNOTICED DUE TO THE COLOR OF THE BALLOON BEING A SIMILAR COLOR TO THAT OF THE SCOPE. A NEW BALLOON WAS THEN APPLIED OVER THE REMNANT AND UTILIZED ON A SECOND PATIENT. THIS PLACED THE PATIENT AT RISK OF POTENTIALLY BEING EXPOSED TO A BLOODBORNE PATHOGEN. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THERE IS A REQUEST TO CONSIDER MANUFACTURING BALLOONS IN A DIFFERENT COLOR OTHER THAN OFF-WHITE, TO ENSURE THE BALLOON IS EASILY IDENTIFIABLE. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795689 ↗