BALLOON MAJ-1351 (REF N5369631)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of BALLOON (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04953170463938), received between Apr 25, 2025 and Sep 16, 2026 — classified as 13 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 Component17
- Incomplete or Inadequate Connection3
- Material Puncture/Hole3
- Break1
- Device Slipped1
- Loss of or Failure to Bond1
- Material Rupture1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
It was reported that during a diagnostic EBUS (endobronchial ultrasound), the balloon was partially torn off when the scope was being withdrawn through the endotracheal tube. The torn piece could not be located or recovered.
Patient problems: Foreign Body In Patient
MAUDE report 50793201 ↗MalfunctionSep 16, 2026Detachment of Device or Device Component
It was reported by the customer that the balloon detached during the withdrawal of the scope. The detached balloon subsequently recovered after being coughed out by the patient. The issue occurred during an Endobronchial Ultrasound (EBUS) procedure. No harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790956 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521706 ↗InjuryJul 28, 2026Detachment of Device or Device Component
No additional information was received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059582 ↗InjuryJul 28, 2026Detachment of Device or Device Component
It was reported that during an unknown procedure, the balloon that was used with the bronchofibervideoscope fell inside the patient. The balloon was successfully retrieved. The procedure was then completed with a similar device. There were no further reports of patient harm.This report is 1 of 2 devices, for the balloon.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058672 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE MAJ-1351 LATEX BALLOON DETACHED FROM THE TIP OF THE SCOPE WHEN PULLING BACK THE ENDOSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832609 ↗InjuryMar 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE BALLOON FELL OFF FROM THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE AND WAS LEFT BEHIND IN THE PATIENT'S AIRWAY DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND. THE PROCEDURE WAS STOPPED AND THE PROVIDER SWITCHED TO A REGULAR BRONCHOSCOPE TO RETRIEVE THE BALLOON FROM THE LEFT MAIN STEM BRONCHUS USING SUCTION. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE WITH A DELAY OF LESS THAN 30 MINUTES. THERE WERE NO REPORTS OF FURTHER PATIENT HARM. THIS REPORT IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557196 ↗MalfunctionMar 3, 2026Break
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497699 ↗InjuryFeb 20, 2026Detachment of Device or Device Component
REPORT 1 OF 2 IT WAS REPORTED THAT DURING AN EBUS (ENDOBRONCHIAL ULTRASOUND) THE BALLOON FELL OFF THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE INTO THE PATIENT¿S LUNG. THE PHYSICIAN NOTICED IT WAS NOT ON THE SCOPE WHEN HE EXITED THE ET TUBE (ENDOTRACHEAL TUBE). THE BALLOON WAS SUCTIONED TO THE TIP OF THE SCOPE, RETRIEVED THROUGH THE ET TUBE AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402387 ↗MalfunctionFeb 10, 2026Incomplete or Inadequate Connection
NO NEW ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307833 ↗MalfunctionFeb 2, 2026Device Slipped; Incomplete or Inadequate Connection
IT WAS REPORTED THE BALLOON CAME LOOSE AND REMAINED HANGING AT THE END OF THE SCOPE DURING A DIAGNOSTIC, ENDOBRONCHIAL ULTRASOUND PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT BALLOON. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24236063 ↗MalfunctionFeb 2, 2026Incomplete or Inadequate Connection
IT WAS REPORTED THAT DURING A DIAGNOSTIC EBUS PROCEDURE, THE BALLOON ON THE EBUS SCOPE BECAME LOOSE AND "REMAINED HANGING AT THE END OF THE SCOPE." THERE WERE NO INJURIES OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24231544 ↗MalfunctionDec 30, 2025Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23921951 ↗MalfunctionDec 4, 2025Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component
THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INFECTION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716588 ↗InjuryJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, UNDER GENERAL ANESTHESIA, THE MAJ-1351 BALLOON FELL OFF INTO THE PATIENT'S AIRWAY. THE BALLOON WAS RETRIEVED WITH DISPOSABLE BIOPSY FORCEPS (MODEL# FB ¿ 211D OLYMPUS) RIGHT AFTER THE SCOPE WAS REMOVED AND THE MISSING PIECE WAS DISCOVERED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT A DELAY AND NO UNPLANNED DIAGNOSTIC TEST WAS REQUIRED. NO REPORTS OF PATIENT HARM. REPORTEDLY, THERE WAS NO PROBLEM WITH PATIENT'S EXTUBATING PROCESS OR RECOVERY. THIS EVENT IS FOR THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332424 ↗InjuryJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, UNDER GENERAL ANESTHESIA, THE MAJ-1351 BALLOON FELL OFF INTO THE PATIENT'S AIRWAY. THE BALLOON WAS RETRIEVED WITH DISPOSABLE BIOPSY FORCEPS (MODEL# FB ¿ 211D OLYMPUS) RIGHT AFTER THE SCOPE WAS REMOVED AND THE MISSING PIECE WAS DISCOVERED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT A DELAY AND NO UNPLANNED DIAGNOSTIC TEST WAS REQUIRED. NO REPORTS OF PATIENT HARM. REPORTEDLY, THERE WAS NO PROBLEM WITH PATIENT'S EXTUBATING PROCESS OR RECOVERY. THIS EVENT IS FOR THE BALLOON. THE COMPLAINT IS RELATED TO THE PATIENT IDENTIFIER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332411 ↗InjuryJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22206813 ↗InjuryJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BALLOON FELL OFF THE SCOPE AND INTO THE PATIENT'S LUNG DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. THE BALLOON WAS RETRIEVED USING FORCEPS. THE PATIENT REPORTEDLY RECOVERED WITHOUT ISSUE. THE FOLLOWING PATIENT IDENTIFIER IS LINKED: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22206673 ↗InjuryJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22195210 ↗InjuryJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, A SECOND BALLOON FELL INTO THE PATIENT'S LUNGS THAT WAS RETRIEVED BY SUCTIONING THE BALLOON AND PULLED IT OUT OF THE PATIENT WITHOUT ANY COMPLICATION. AFTER THE PROCEDURE, THE PATIENT WAS STABLE AND WENT HOME. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22195167 ↗InjuryJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE BALLOON FELL INTO THE PATIENT'S LUNGS THAT WAS RETRIEVED BY SUCTIONING THE BALLOON AND PULLED IT OUT OF THE PATIENT WITHOUT ANY COMPLICATION. AFTER THE PROCEDURE, THE PATIENT WAS STABLE AND WENT HOME. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22188077 ↗InjuryJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE BALLOON FELL INTO THE PATIENT'S LUNGS THAT WAS RETRIEVED BY SUCTIONING THE BALLOON AND PULLED IT OUT OF THE PATIENT WITHOUT ANY COMPLICATION. AFTER THE PROCEDURE, THE PATIENT WAS STABLE AND WENT HOME. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22188066 ↗MalfunctionMay 29, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE PACKAGE, THE BALLOONS HAD HOLES IN THEM. THIS OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22104045 ↗MalfunctionMay 29, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE PACKAGE, THE BALLOONS HAD HOLES IN THEM. THIS OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22103953 ↗MalfunctionApr 25, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE BALLOON HAD HOLE IN IT. THE ISSUE OCCURRED DURING UNPACKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21913091 ↗
Other Bronchoscope (Flexible Or Rigid) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 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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