BALLOON3 MAJ-249 (UDI 04953170360442)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170360442), received between Mar 18, 2024 and Mar 18, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, A BALLOON FELL OFF INSIDE OF A PATIENT. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. THERE WAS NO DELAY AND WHEN THE PROBLEM WAS NOTICED THE BALLOON WAS RETRIEVED, THE DEVICE WAS PULLED AND THE PROCEDURE ENDED. THE LAST PART OF THE PROCEDURE WASN'T COMPLETED, BUT ENOUGH SPECIMENS HAD BEEN COLLECTED PRIOR TO THE BALLOON FALLING OFF. THERE WERE NO REPORTS OF HARM TO THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18926791 ↗InjuryMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, A BALLOON FELL OFF INSIDE OF A PATIENT. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. THERE WAS NO DELAY AND WHEN THE PROBLEM WAS NOTICED THE BALLOON WAS RETRIEVED, THE DEVICE WAS PULLED AND THE PROCEDURE ENDED. THE LAST PART OF THE PROCEDURE WASN'T COMPLETED, BUT ENOUGH SPECIMENS HAD BEEN COLLECTED PRIOR TO THE BALLOON FALLING OFF. THERE WERE NO REPORTS OF HARM TO THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18926767 ↗
Other Endoscopic ultrasound system, gastroenterology-urology devices
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- PENTAX EG-3870UTKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology164 reports
- PENTAX Medical EG36-J10URHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology126 reports
- PENTAX EG-3670URKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology72 reports
- PENTAX Medical EG34-J10UHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology61 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology29 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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