BALLOONRecalls & reported problems across all models
Olympus Medical Systems Corp. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 248
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls
- 0
We found 4 models of BALLOON by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 248 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2018 and Sep 16, 2026 — classified as 64 injuries, 184 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (74 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BALLOON problems
Device problems
- Detachment of Device or Device Component74
- Material Rupture53
- Material Puncture/Hole31
- Material Split, Cut or Torn20
- Break15
- Device Reprocessing Problem15
- Separation Problem14
- Device Dislodged or Dislocated12
Patient problems
- No Clinical Signs, Symptoms or Conditions203
- Foreign Body In Patient22
- No Consequences Or Impact To Patient12
- No Patient Involvement6
- Airway Obstruction5
- Device Embedded In Tissue or Plaque2
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
BALLOON models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BALLOON MAJ-1351Gastroscope and accessories, flexible/rigid174 reports
- BALLOON MAJ-1351Endoscopic ultrasound system, gastroenterology-urology29 reports
- BALLOON MAJ-1351Bronchoscope (Flexible Or Rigid)25 reports
- Balloon MAJ-213Gastroscope And Accessories, Flexible/Rigid20 reports
Recent BALLOON adverse event reports
The 15 most recent reports across all models, 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that during a diagnostic EBUS (endobronchial ultrasound), the balloon was partially torn off when the scope was being withdrawn through the endotracheal tube.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 ↗InjuryMar 2, 2026Detachment of Device or Device Component
MEDWATCH REPORT MW5181872 RECEIVED AND REPORTED THE FOLLOWING: PATIENT WAS UNDERGOING A BRONCHOSCOPY USING AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPE (EBUS). AT THE END OF THE PROCEDURE, IT WAS IDENTIFIED THAT THE EBUS BALLOON WAS MISSING. THE PATIENT UNDERWENT AN ADDITIONAL BRONCHOSCOPY X 2, ENDOSCOPY X 1 AND CT OF CHEST WITH NO RETAINED BALLOON IDENTIFIED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER: THE INITIAL PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND WAS PROLONGED FOR APPROXIMATELY ONE HOUR TO SEARCH FOR THE MISSING BALLOON. THE REPORTED PROBLEM NO AFFECT THE DIAGNOSTIC OUTCOME OF THE PROCEDURE. THIS REPORT IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492080 ↗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 17, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364075 ↗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 ↗InjuryJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT AFTER AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, THE BALLOON WAS NOTICED MISSING DURING BED SIDE SCOPE CLEAN. IT WAS DETACHED FROM THE BRONCHOVIDEOSCOPE. THE PATIENT WAS BROUGHT BACK FROM THE RECOVERY ROOM BACK INTO PROCEDURE ROOM FOR A SECONDARY PROCEDURE TO REMOVE THE BALLOON. THE BALLOON WAS FOUND IN THE LARYNGEAL MASK AIRWAY (LMA) AND WAS REMOVED SUCCESSFULLY. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THIS COMPLAINT IS #1 OF 2 DEVICES, FOR THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24040170 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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