Balloon2 MH-303 (UDI 04953170355721)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170355721), received between Feb 3, 2023 and Oct 1, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL ON THE BALLOON AND MOISTURE CAUSED RUST TO FORM ON THE OXYGEN ABSORBER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343118 ↗
• MalfunctionDec 20, 2023Problem with Sterilization; Problem with Sterilization

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE BALLOON WAS USED ON PATIENTS WITHOUT THE GAS STERILIZATION PRIOR TO BEING USED. IT WAS USED ON MULTIPLE PATIENTS FROM MAY TO NOVEMBER OF THIS YEAR (2023). THE BALLOON WAS USED DURING A DIAGNOSTIC ULTRASOUND ENDOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR HEALTH DAMAGE. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370147 ↗
• MalfunctionDec 11, 2023Problem with Sterilization; Problem with Sterilization

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BALLOON WAS USED DURING A DIAGNOSTIC ULTRASOUND ENDOSCOPY PROCEDURE. THE CUSTOMER HAD NOT PERFORMED GAS STERILIZATION OF THE BALLOON PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR HEALTH DAMAGE. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIERS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301853 ↗
• MalfunctionDec 6, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THAT AN UNSTERILIZED BALLOON 2 WAS USED IN A PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF HARM TO PATIENTS. THE DISTRIBUTOR CHECKED WITH CUSTOMER INFORMATION CENTER TO SEE IF BALLOON 2 COULD BE STERILIZED WITH STELLAD. IT WAS DISCOVERED THAT THE FACILITY WAS UNABLE TO HANDLE GAS STERILIZATION, AND THAT AN UNSTERILIZED ULTRASONIC BALLOON WAS MISUSED. THE BALLOON HAD NOT BEEN USED SINCE THE DISCOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273606 ↗
• MalfunctionNov 28, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BALLOON WAS USED DURING A DIAGNOSTIC ULTRASOUND ENDOSCOPY PROCEDURE WITHOUT GAS STERILIZATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR HEALTH DAMAGE. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222432 ↗
• MalfunctionSep 21, 2023Problem with Sterilization; Problem with Sterilization

  THE CUSTOMER REPORTED TO OLYMPUS, THE BALLOON2 MAY HAVE BEEN USED NON-STERILE IN A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789353 ↗
• MalfunctionSep 19, 2023Failure to Clean Adequately; Failure to Clean Adequately

  CIC SAFETY NOTIFIED OLYMPUS BY MAIL THAT DURING A DIAGNOSTIC ULTRASOUND ENDOSCOPE PROCEDURE, AN UNSTERILIZED BALLOON 2 WAS USED ON A PATIENT. THERE WERE NO REPORTS OF PATIENT HARM. RELATED TO PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777555 ↗
• MalfunctionSep 1, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT HIS OLYMPUS BALLOON2 MAY HAVE INADVERTENTLY BEEN USED ON A PATIENT AFTER HAVING BEEN INSUFFICIENTLY REPROCESSED. THERE HAS BEEN NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669854 ↗
• MalfunctionAug 30, 2023Device Reprocessing Problem; Device Reprocessing Problem

  A USER FACILITY REPORTED TO OLYMPUS THE POSSIBLE USE OF NON-STERILE BALLOON2 ON A PATIENT. THERE WERE NO REPORTS OF PATIENT HARM FOR THE UNIDENTIFIED DIAGNOSTIC PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653342 ↗
• MalfunctionAug 28, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT A NON-STERILE BALLOON2 WAS POSSIBLY USED ON A PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631708 ↗
• MalfunctionAug 16, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT AN OLYMPUS BALLOON MAY HAVE BEEN INSUFFICIENTLY REPROCESSED AND USED DURING A DIAGNOSTIC ULTRASONIC ENDOSCOPY PROCEDURE. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT. THIS REPORT IS RELATED TO REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556917 ↗
• MalfunctionFeb 3, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE CUSTOMER REPORTED THAT, WHEN THE FACILITY CHECKED THE PACKAGE INSERT, THE PACKAGE INSERT FOR THE SUBJECT DEVICE STATES THAT STERILIZATION IS REQUIRED, BUT THE PRODUCT PACKAGE LABEL STATES STERILIZE AS NEEDED. THIS WAS THE FIRST TIME THE DISCREPANCY WAS NOTED, AND THE FACILITY HAD PREVIOUSLY USED THE PRODUCT WITHOUT STERILIZATION. THERE HAVE BEEN NO REPORTS OF INFECTION AND DOCTORS HAVE NOT SEEN IT AS A PROBLEM, BUT THE CUSTOMER HAS COMPLAINED THAT THERE MAY BE A PROBLEM WITH THE WAY OLYMPUS WRITES IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293787 ↗