Balloon MAJ-213Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170355714), received between Sep 2, 2022 and Sep 14, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2023Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED TO OLYMPUS, A BALLOON WAS POSSIBLY USED UNSTERILIZED ON A PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749005 ↗
• MalfunctionSep 13, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, AN UNSTERILIZED BALLOON MAY HAVE BEEN USED ON A PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17734302 ↗
• MalfunctionSep 12, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, AN UNSTERILIZED BALLOON WAS USED ON A PATIENT. THE INTENDED PROCEDURE WAS AN ULTRASONIC ENDOSCOPE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17727208 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THERE WAS A POSSIBILITY A NON-STERILE BALLOON WAS USED ON A PATIENT. THE EVENT OCCURRED DURING AN ULTRASOUND ENDOSCOPE DIAGNOSTIC PROCEDURE. THERE WAS NO REPORT OF PATIENT CONTAMINATION, HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647725 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Problem with Sterilization; Device Reprocessing Problem; Problem with Sterilization

  A USER FACILITY REPORTED TO OLYMPUS THAT A NON-STERILE BALLOON WAS USED ON A PATIENT. THE EVENT OCCURRED DURING AN ULTRASOUND ENDOSCOPE DIAGNOSTIC PROCEDURE. THERE WAS NO REPORT OF PATIENT CONTAMINATION, HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647701 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640989 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHEN THE DIAGNOSTIC ENDOSCOPIC ULTRASOUND (EUS) TEST WAS DONE, THERE WAS A POSSIBILITY THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640911 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHEN THE DIAGNOSTIC ENDOSCOPIC ULTRASOUND (EUS) TEST WAS DONE, THERE WAS A POSSIBILITY THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640832 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640471 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640441 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640398 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHEN THE DIAGNOSTIC ENDOSCOPIC ULTRASOUND (EUS) TEST WAS DONE, THERE WAS A POSSIBILITY THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640345 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640287 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640250 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT A NON-STERILE BALLOON MAY HAVE BEEN USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640213 ↗
• MalfunctionAug 17, 2023Device Reprocessing Problem; Device Reprocessing Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564144 ↗
• MalfunctionAug 16, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT HIS OLYMPUS BALLOON WAS INSUFFICIENTLY REPROCESSED PRIOR TO POTENTIALLY BEING USED ON A PATIENT DURING A DIAGNOSTIC ULTRASOUND ENDOSCOPE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556448 ↗
• MalfunctionApr 27, 2023Problem with Sterilization; Problem with Sterilization

  IT WAS REPORTED, THE CUSTOMER DID NOT READ THE STERILIZATION INSTRUCTIONS. AND THE BALLOON MAY NOT HAVE BEEN STERILIZED AS THE CUSTOMER CLAIMED. NO INSTRUCTION WAS RECEIVED TO STERILIZE THE DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. PATIENT IDENTIFIER (B)(6) CAPTURES A RELATED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823142 ↗
• 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 16294087 ↗
• MalfunctionSep 2, 2022Contamination; Material Puncture/Hole; Contamination; Material Puncture/Hole

  AS REPORTED, 1PC OF MAJ-213 HAS STAIN IN THE SURFACE AND 1PC OF MAJ-213 HAS A HOLE WITH LOT NUMBER #18R. THE ISSUE FOUND AT PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15344976 ↗