Olympus BD-400P-1380Recalls & reported problems
Gyrus ACMI, LLC · EZDilate - Fixed Wire Esophageal 3-Stage Balloon Dilatation Catheter 11-13mm · Class 2
All models of Olympus (27)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925033184), received between Aug 21, 2023 and Nov 5, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 10, 2023Open, Classified
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Z-0935-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THE EASY DILATE BALLOON DILATOR EXHIBITED DILATATION BALLOON POP. THE ISSUE OCCURRED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482800 ↗MalfunctionSep 16, 2024
THE ESOPHAGEAL BALLOON DID NOT COMPLETELY DEFLATE WITH EQUIPMENT USED FOR THIS, NEEDED TO MANUALLY DEFLATE WITH A SYRINGE. DILATOR WOULD NOT LOCK, AND BALLOON WOULD NOT STAY DILATED TO MM SETTING, YOU HAD TO CONTINUOUSLY ADD TO BALLOON.
Patient problems: Insufficient Information
MAUDE report 20225399 ↗MalfunctionAug 21, 2023Failure to Deflate; Failure to Deflate
THE CUSTOMER REPORTED THAT WHILE PERFORMING AN ESOPHAGEAL DILATATION PROCEDURE, HIS OLYMPUS EZ-DILATE BALLOON DILATOR EXPERIENCED A REMOVAL ISSUE. ACCORDING TO THE INITIAL REPORTER, AFTER INFLATING THE UNIT TO 13MM, IT WAS UNABLE TO BE RETRACTED FROM THE FORCEPS PORT OF THE ENDOSCOPE. REPORTEDLY, THIS CAUSED THE ENTIRE ENDOSCOPE TO BE REMOVED AND THE BALLOON TIP WAS CUT WITH PLIERS. AS THIS OCCURRED IN THE FINAL EXPANSION STAGE, THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT HARM CAUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17584737 ↗
Other Dilator, esophageal devices
- CRE Fixed Wire M00558380Boston Scientific Corporation · Dilator, esophageal359 reports
- CRE Fixed Wire M00558370Boston Scientific Corporation · Dilator, esophageal219 reports
- XXL™ Esophageal M001145590Boston Scientific Corporation · Dilator, esophageal116 reports
- Olympus BD-400P-2080Gyrus ACMI, LLC · Dilator, esophageal1 recall60 reports
- CRE Wireguided M00558500Boston Scientific Corporation · Dilator, esophageal1 recall58 reports
- Olympus BD-400P-1580Gyrus ACMI, LLC · Dilator, esophageal2 recalls4 reports
- XXL™ Esophageal M001145520Boston Scientific Corporation · Dilator, esophageal102 reports
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 recalls0 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 · each recall links to the FDA recall notice
- 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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