Olympus BD-400P-1580Recalls & reported problems
Gyrus ACMI, LLC · EZDilate - Fixed Wire Esophageal 3-Stage Balloon Dilatation Catheter 13.5-15.5mm · Class 2
All models of Olympus (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925033191), received between May 19, 2022 and Aug 27, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
2 FDA recall records name this device's identifier, 2 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 18, 2026.
Reports received per month
Recalls naming this device
- Nov 10, 2023Class IIOpen, 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-0937-2024 · Root cause: Process control · Recall details · FDA record ↗
- Nov 10, 2023Class IIOpen, 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-0936-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Burst Container or Vessel1
- Deflation Problem1
- Difficult to Remove1
- Failure to Deflate1
- Material Rupture1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Deflation Problem; Difficult to Remove; Obstruction of Flow; Deflation Problem; Difficult to Remove; Obstruction of Flow
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901769 ↗MalfunctionSep 6, 2023Material Rupture; Material Rupture
THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE EZDILATE BALLOON DILATOR INFLATED THE BALLOON TO 14.5 MILLIMETERS AND BURST DURING DILATION. THE ISSUE OCCURRED DURING THE MIDDLE OF A THERAPEUTIC ESOPHAGEAL DILATION PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS AN UNKNOWN DELAY AND THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17691046 ↗InjuryAug 2, 2023Burst Container or Vessel; Burst Container or Vessel
THE CUSTOMER REPORTED TO OLYMPUS THAT THE EZDILATE BALLOON DILATOR BURST DURING AN ESOPHAGOGASTRODUODENOSCOPY. THE BALLOON WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SIMILAR DEVICE. THERE WAS A SMALL PINHOLE LEAK FROM THE BALLOON, BUT NO PIECES WERE MISSING. THERE WAS NO FURTHER IMPACT TO THE PATIENT AND NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17442430 ↗MalfunctionMay 19, 2022Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT AN ULTRASOUND BALLOON WOULD NOT DEFLATE DURING A CASE. ACCORDING TO THE REPORTER, TWO (2) DIFFERENT BALLOONS WERE USED IN THE SAME CASE, BUT WITH THE SAME ISSUE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (SECOND BALLOON).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14447031 ↗
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
- XXL™ Esophageal M001145520Boston Scientific Corporation · Dilator, esophageal102 reports
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 recalls0 reports
- CRE Fixed Wire M00558360Boston Scientific Corporation · Dilator, esophageal93 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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