EZDilate BD-410X-1555Recalls & reported problems
Gyrus ACMI, LLC · EZDilate 3-Stage Balloon Dilator (Wire Guided) 13.5-14.5-15.5 mm diameter · Class 2
All models of EZDilate (7)
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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925033252), received between Jan 18, 2024 and Oct 4, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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-0942-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Burst Container or Vessel2
- Difficult to Remove1
- Inflation 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.
InjuryOct 4, 2024Burst Container or Vessel; Inflation Problem; Difficult to Remove; Burst Container or Vessel; Inflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING A COLONOSCOPY PROCEDURE, THE BALLOON EXPLODED INSIDE OF THE PATIENT WHEN THE NURSE WAS INFLATING. THEY HAD ATTEMPTED TO REACH 15 MMHG BUT THIS WAS IMPOSSIBLE, AND THE BALLOON BURST AT 6 MMHG. THE DOCTOR WAS NOT ABLE TO REMOVE THE BALLOON FROM THE SCOPE, SO THEY HAD TO REMOVE THE SCOPE FROM THE PATIENT, CUT THE BALLOON, AND REPEAT THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE REPORTS OF NO FRAGMENTS RETAINED AFTER THE BALLOON BURST. IT TOOK SOME TIME TO THE GET ANOTHER BALLOON AND NO ADDITIONAL SEDATION WAS REQUIRED. THE CONDITION OF THE PATIENT WAS NOT AFFECTED BY THE FAILURE. THE PATIENT IS REPORTED TO BE FINE POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20369141 ↗InjuryMay 21, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED, THE BALLOON DILATATION CATHETER DID NOT INFLATE WHILE INSIDE THE PATIENT. IT WAS FURTHER NOTED THAT IT HAD BURST AND THAT BROKEN PARTS WERE RETRIEVED FROM THE PATIENT USING THE SCOPE. THE ISSUE OCCURRED DURING A DIAGNOSTIC STENT INSERTION FOR DILATION PROCEDURE. THERE WAS A 5-MINUTE DELAY AND THE PROCEDURE WAS THEN COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359055 ↗MalfunctionJan 18, 2024
UPON ATTEMPT TO DILATE, THE BALLOON WOULD NOT EXPAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18535588 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page