Olympus BD-410X-1355Recalls & reported problems
Gyrus ACMI, LLC · EZDilate 3-Stage Balloon Dilator (Wire Guided) 11-12-13 mm diameter · Class 2
All models of Olympus (27)
Data updated Oct 18, 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821925033245), received between May 19, 2022 and Jul 28, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
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 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-0941-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture2
- Break1
- Burst Container or Vessel1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Material Rupture; Material Rupture
IT WAS REPORTED THE EZDILATE BALLOON DILATOR WOULD NOT HOLD STERILE WATER AND STAY INFLATED. THE ISSUE OCCURRED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY PROCEDURE AND WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637339 ↗MalfunctionMar 29, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED, THAT THE BALLOON DILATATION CATHETER HAD THE BALLOON LEAK. THE ISSUE WAS FOUND DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE WHICH WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008324 ↗MalfunctionSep 20, 2023Material Rupture; Material Rupture
THE CUSTOMER REPORTED THAT HER OLYMPUS EZ-DILATE BALLOON DILATOR RUPTURED DURING THE THIRD INFLATION OF A PROCEDURE. THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM DONE TO THE PATIENT AS A RESULT OF THIS EVENT. THIS INFORMATION REFLECTS WHAT WAS RECEIVED FROM THE FDA IN THE FORM OF NOTIFICATION PER 803.22.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17780484 ↗MalfunctionJun 8, 2023Break; Break
ADDITIONAL INFORMATION WAS PROVIDED. THE INTENDED PROCEDURE WAS DELAYED AND THE PATIENT'S ANESTHESIA OR SEDATION WAS EXTENDED NOT MORE THAN FIVE MINUTES, TO ALLOW THE USER TO PULL ANOTHER BALLOON. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17092013 ↗MalfunctionMay 19, 2022Crack; Crack
DURING AN ESOPHAGEAL DILATATION SURGERY, THE BALLOON WAS PUMPED TO 2 ATM ( MAX. 5.5. ATM) AND SUDDENLY CRACKED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14434629 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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