EZDilateRecalls & reported problems across all models
Gyrus ACMI, LLC · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one EZDilate model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 6
We found 7 models of EZDilate by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2021 and Sep 23, 2026 — classified as 10 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (13 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EZDilate recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 17, 2025Open, Classified
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
Z-0572-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 13, 2024Open, Classified
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
Z-0225-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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-0944-2024 · Root cause: Process control · Recall details · FDA record ↗
- 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-0943-2024 · Root cause: Process control · Recall details · FDA record ↗
- 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-0942-2024 · Root cause: Process control · Recall details · FDA record ↗
- 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-0940-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported EZDilate problems
Device problems
- Material Rupture13
- Break5
- Burst Container or Vessel5
- Deflation Problem3
- Difficult to Remove2
- Defective Device1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient1
EZDilate models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EZDilate BD-410X-1055Dilator, esophageal2 recalls0 reports
- EZDilate BD-410X-2055Dilator, esophageal1 recall18 reports
- EZDilate BD-410X-1855Dilator, esophageal1 recall8 reports
- EZDilate BD-410X-1555Dilator, esophageal1 recall3 reports
- EZDilate BPCN0815KCATHETER, NEPHROSTOMY1 recall1 report
- EZDilate BPCN1015CATHETER, NEPHROSTOMY2 reports
- EZDilate BPCN1015KCATHETER, NEPHROSTOMY1 report
Recent EZDilate adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Burst Container or Vessel
It was reported that the wire guided balloon dilator burst during a diagnostic esophagogastroduodenoscopy. The procedure was completed using a competitor device. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863814 ↗MalfunctionSep 18, 2026Break
It was reported that the balloon broke while inside of the patient involving an Olympus Dilator. The issue occurred during esophagogastroduodenoscopy with dilation procedure. No information regarding whether any pieces broke off inside the patient or if retrieval was required. The procedure was completed with an Olympus back-up device. There was no patient reported harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816902 ↗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 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THE USER OF THE BALLOON DILATOR HEARD A POP AND THEY REALIZED THE CASING HAD BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC COLONOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319293 ↗MalfunctionDec 5, 2025Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728402 ↗MalfunctionJul 17, 2025Entrapment of Device; Device Dislodged or Dislocated
WHEN REMOVING THE DEVICE FROM THE SCOPE THE DISTAL BALLOON SEGMENT PULLED COMPLETELY AWAY FROM THE DEVICE. THE BALLOON LODGED INTO THE DISTAL PORT OF THE SCOPE AND WAS ABLE TO BE RETRIEVED ONCE THE SCOPE WAS WITHDRAWN FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529784 ↗MalfunctionMay 14, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22021683 ↗MalfunctionMay 14, 2025Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22021613 ↗MalfunctionJan 23, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE WIRE BROKE DURING A BALLOON REMOVAL. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21223048 ↗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 ↗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 ↗MalfunctionFeb 13, 2024Explosion; Explosion
IT WAS REPORTED, THE BALLOON DILATOR BALLOON HAD BURST DURING PROCEDURE BEFORE DILATING TO 20 MM. THE ISSUE OCCURRED IN THE MIDDLE OF A THERAPEUTIC ESOPHAGEAL DILATION. THERE WERE NO REPORTS OF DELAYS. THE BURST BALLOON WAS RETRIEVED FROM THE PATIENT WITH NO ISSUES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18696934 ↗MalfunctionJan 23, 2024
BALLOON DILATION OF TWO PLACES IN PATIENT'S ESOPHAGUS, AFTER THE SECOND TIME THE BALLOON AFTER DEFLATION WOULD NOT COME BACK THROUGH THE SCOPE. UPON REMOVING SCOPE WITH BALLOON STILL THROUGH IT, IT WAS NOTICED THAT THE WIRE HAD GOTTEN A KINK IN IT AT THE END WHICH WOULD NOT ALLOW IT TO WITHDRAWAL THROUGH THE SCOPE. WIRECUTTERS HAD TO BE USED TO REMOVED THE BENT PART OF THE WIRE AND REMOVE THE BALLOON FROM THE SCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18562957 ↗
Other Gyrus ACMI, LLC products
- SOLTIVE16 models · 867 reports · 17 recalls
- Olympus27 models · 518 reports · 21 recalls
- SHOCKPULSE11 models · 580 reports · 5 recalls
- Spiration Valve System10 models · 242 reports · 1 recall
- BiCOAG4 models · 36 reports · 5 recalls
- USA Elite24 models · 78 reports · 3 recalls
- M3 Gold5 models · 30 reports · 2 recalls
- PK TECHNOLOGY10 models · 24 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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