Olympus BD-400P-1080Recalls & reported problems
Gyrus ACMI, LLC · EZDilate - Fixed Wire Esophageal 3-Stage Balloon Dilatation Catheter 8.5-10.5 mm · 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 00821925033177), received between Jul 1, 2021 and Jan 23, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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-0934-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture1
- Material Split, Cut or Torn1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2024
DILATION BALLOON RUPTURED WHILE IN PATIENT. BALLOON WAS BEING INFLATED PAST 7 ATMOSPHERES FOR A 9.5MM DIAMETER WHEN IT HAPPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18562919 ↗MalfunctionJul 25, 2023Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT WHILE HOLDING PRESSURE AT 9.5 ATM (ATMOSPHERIC PRESSURE), THE DEVICE WAS SUDDENLY LOST PRESSURE . UPON INSPECTION, IT WAS FOUND THE BALLOON HAD SPLIT DOWN THE SIDE. THE DEVICE WAS REPLACED AND THE INTENDED DIAGNOSTIC AN UNSPECIFIED PROCEDURE WAS COMPLETED USING ANOTHER DILATOR BALLOON (SIMILAR DEVICE). THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17387122 ↗MalfunctionJul 1, 2021Material Rupture; Material Rupture
AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN UNKNOWN THERAPEUTIC PROCEDURE, THE BALLOON WAS INFLATED AND DEFLATED PRIOR TO THE BALLOON RUPTURING AFTER INFLATION. ALL THE BALLOON PIECES WERE RECOVERED. THERE IS NO REPORTED HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12100430 ↗
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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