EZDilate BD-410X-1855Recalls & reported problems
Gyrus ACMI, LLC · EZDilate 3-Stage Balloon Dilator (Wire Guided) 16-17-18 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
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821925033269), received between Feb 9, 2021 and Aug 7, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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-0943-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture3
- Deflation Problem2
- Break1
- Detachment of Device or Device Component1
- Difficult to Remove1
- Failure to Deflate1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Break; Deflation Problem; Difficult to Remove
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168846 ↗MalfunctionMar 22, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED, THE EZDILATE BALLOON DILATOR (WG) 16-17-18 WAS FILLED UP THE FIRST TIME AND IT FULFILLED ITS FUNCTION. WHEN THE BALLOON WAS REFILLED, IT WAS LEAKING. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPACIFICATION (ERCP) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18959690 ↗MalfunctionMar 18, 2024
DILATION BALLOON CATHETER SNAPPED INSIDE OF THE SCOPE WHILE PULLING THE CATHETER OUT OF THE SCOPE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920749 ↗InjuryDec 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT WHEN USING AN EZDILATE BALLOON DILATOR, THE WHITE TIP ON THE END "BLEW OFF" INSIDE THE PATIENT. THE PIECE WAS RETRIEVED BUT THE DILATATION PORTION OF THE PROCEDURE WAS UNABLE TO BE PERFORMED. THE PROCEDURE WAS COMPLETED BUT THE THERAPEUTIC PORTION WILL BE RESCHEDULED FOR A LATER DATE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320236 ↗MalfunctionJun 3, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) BILE DUCT DILATATION FOR STONE EXTRACTION THE BALLOON CATHETER BURTS BETWEEN PROCEDURE WHEN IT WAS ALREADY INFLATED. THE INTENDED PROCEDURE WAS COMPLETED WITH OTHER COMPANY DEVICE. THERE WAS NO PATIENT INJURY REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11929381 ↗MalfunctionJun 2, 2021Deflation Problem; Material Rupture; Deflation Problem; Material Rupture
IT WAS REPORTED THAT THE BALLOON BURST/RUPTURE DURING DILATION PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. THE LOT NUMBER USED WAS NOT PROVIDED. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11920257 ↗MalfunctionMar 19, 2021Failure to Deflate; Failure to Deflate
BALLOON WOULD NOT DEFLATE COMPLETELY AND GOT STUCK TRYING TO REMOVE FROM THE SCOPE. THE BALLOON THEN BROKE ON THE SHEATH. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR IMPACT REPORTED. NO USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11528216 ↗MalfunctionFeb 9, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ESOPHAGEAL ANASTOMOTIC DILATION PROCEDURE USING AN EZDILATE BALLOON, THE BALLOON BROKE. THE BALLOON EXPANSION HAD REACHED THE TARGET PRESSURE, HOWEVER, THE BALLOON HAD THEN RUPTURED/BURST. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. ACCORDING TO THE DOCTOR, THE BALLOON MAY HAVE BURST IN CONTACT WITH A STAPLER OR THE LIKE. THE BROKEN BALLOON WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11304104 ↗
Other Dilator, esophageal devices
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- 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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