EZDilate BD-410X-2055Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00821925033276), received between Dec 10, 2021 and Sep 23, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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.

Recalls naming this device

1. 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-0944-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 30, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE POPPED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THE PROCEDURE WAS PROLONGED BY 5 TO 10 MINUTES AND THE PATIENT'S ANESTHESIA WAS EXTENDED BY 15 TO 20 MINUTES. THE MINOR EXTENSION OF THE PROCEDURE AND ANESTHESIA POSES NO ADDITIONAL HARM, AND THE PATIENT WAS CONFIRMED TO HAVE HAD NO IMPACT FROM THE FAILURE. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655185 ↗
• InjuryAug 18, 2023Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTED THAT AN EZDILATE BALLOON DILATOR BURST DURING A THERAPEUTIC DILATATION OF THE BILE DUCTS. NO PARTS CAME LOOSE FROM THE BALLOON. THE PROCEDURE WAS PROLONGED FOR AN UNSPECIFIED DURATION WITH NO IMPACT TO THE PATIENT AND WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572505 ↗
• InjuryDec 19, 2022Material Rupture; Material Rupture

  AN OLYMPUS TERRITORY MANAGER REPORTED A COMPLAINT ON BEHALF OF THE CUSTOMER, STATING THAT DURING AN UNSPECIFIED PROCEDURE, THE CUSTOMER HAD SIX BALLOONS POPPED INSIDE OF PATIENTS. THEY HAVE ALL BEEN 18-20MM BALLOONS AND BELIEVED TO ALL WIRE-GUIDED. THE BALLOONS WERE COMPLETELY RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM REPORTED. THIS IS 6 OF 6 REPORTS: #1 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT #354263; #2 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT #345028; #3 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿; #4 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿; #5 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿; #6 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005766 ↗
• InjuryDec 19, 2022Material Rupture; Material Rupture

  AN OLYMPUS TERRITORY MANAGER REPORTED A COMPLAINT ON BEHALF OF THE CUSTOMER, STATING THAT DURING AN UNSPECIFIED PROCEDURE, THE CUSTOMER HAD SIX BALLOONS POPPED INSIDE OF PATIENTS. THEY HAVE ALL BEEN 18-20MM BALLOONS AND BELIEVED TO ALL WIRE-GUIDED. THE BALLOONS WERE COMPLETELY RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM REPORTED. THIS IS 5 OF 6 REPORTS: #(B)(6)/ MODEL BD-410X-2055 / LOT #354263. #(B)(6)/ MODEL BD-410X-2055 / LOT #345028. #(B)(6)/ MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿. #(B)(6)/ MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿. #(B)(6)/ MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿. #(B)(6)/ MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005740 ↗
• InjuryDec 19, 2022Material Rupture; Material Rupture

  AN OLYMPUS TERRITORY MANAGER REPORTED A COMPLAINT ON BEHALF OF THE CUSTOMER, STATING THAT DURING AN UNSPECIFIED PROCEDURE, THE CUSTOMER HAD SIX BALLOONS POPPED INSIDE OF PATIENTS. THEY HAVE ALL BEEN 18-20MM BALLOONS AND BELIEVED TO ALL WIRE-GUIDED. THE BALLOONS WERE COMPLETELY RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM REPORTED. THIS IS 4 OF 6 REPORTS: #1 OF 6: C22475186, MODEL BD-410X-2055, LOT #354263; #2 OF 6: C22500330, MODEL BD-410X-2055, LOT #345028; #3 OF 6: C22500356, MODEL BD-410X-2055, LOT # ¿UNKNOWN¿; #4 OF 6: C22500379, MODEL BD-410X-2055, LOT # ¿UNKNOWN¿; #5 OF 6: C22500393, MODEL BD-410X-2055, LOT # ¿UNKNOWN¿; #6 OF 6: C22500405, MODEL BD-410X-2055, LOT # ¿UNKNOWN.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005680 ↗
• InjuryDec 19, 2022Material Rupture; Material Rupture

  AN OLYMPUS TERRITORY MANAGER REPORTED A COMPLAINT ON BEHALF OF THE CUSTOMER, STATING THAT DURING AN UNSPECIFIED PROCEDURE, THE CUSTOMER HAD SIX BALLOONS POPPED INSIDE OF PATIENTS. THEY HAVE ALL BEEN 18-20MM BALLOONS AND BELIEVED TO ALL WIRE-GUIDED. THE BALLOONS WERE COMPLETELY RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM REPORTED. THIS IS 3 OF 6 REPORTS: #1 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT #354263, #2 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT #345028, #3 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿, #4 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿, #5 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿, #6 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005620 ↗
• InjuryDec 19, 2022Material Rupture; Material Rupture

  AN OLYMPUS TERRITORY MANAGER REPORTED A COMPLAINT ON BEHALF OF THE CUSTOMER, STATING THAT DURING AN UNSPECIFIED PROCEDURE, THE CUSTOMER HAD SIX BALLOONS POPPED INSIDE OF PATIENTS. THEY HAVE ALL BEEN 18-20MM BALLOONS AND BELIEVED TO ALL WIRE-GUIDED. THE BALLOONS WERE COMPLETELY RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM REPORTED. THIS IS 2 OF 6 REPORTS: #1 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT #354263, #2 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT #345028, #3 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿, #4 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿, #5 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿, #6 OF 6: (B)(6) / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005598 ↗
• InjuryDec 19, 2022Material Rupture; Material Rupture

  AN OLYMPUS TERRITORY MANAGER REPORTED A COMPLAINT ON BEHALF OF THE CUSTOMER, STATING THAT DURING AN UNSPECIFIED PROCEDURE, THE CUSTOMER HAD SIX BALLOONS POPPED INSIDE OF PATIENTS. THEY HAVE ALL BEEN 18-20MM BALLOONS AND BELIEVED TO ALL WIRE-GUIDED. THE BALLOONS WERE COMPLETELY RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM REPORTED. THIS IS 1 OF 6 REPORTS: 1 OF 6: C22475186 / MODEL BD-410X-2055 / LOT #354263. 2 OF 6: C22500330 / MODEL BD-410X-2055 / LOT #345028. 3 OF 6: C22500356 / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿. 4 OF 6: C22500379 / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿. 5 OF 6: C22500393 / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿. 6 OF 6: C22500405 / MODEL BD-410X-2055 / LOT # ¿UNKNOWN¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005585 ↗
• MalfunctionNov 10, 2022Material Rupture; Material Rupture

  AN OLYMPUS REPRESENTATIVE CONTACTED THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), TO REPORT 2 BALLOONS POPPED INSIDE THE PATIENT AND WERE REMOVED WITHOUT AN ADDITIONAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776246 ↗
• MalfunctionNov 10, 2022Material Rupture; Material Rupture

  AN OLYMPUS REPRESENTATIVE CONTACTED THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), TO REPORT 2 BALLOONS POPPED IN THE PATIENT AND WERE REMOVED WITHOUT AN ADDITIONAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776151 ↗
• MalfunctionDec 10, 2021Deflation Problem; Defective Device; Material Split, Cut or Torn; Deflation Problem; Defective Device; Material Split, Cut or Torn

  AS REPORTED , ONE OF THE DILATION BALLOON 18-20MM GOT STUCK AND USER HAD TO CUT IT TO RELEASE IT INSIDE THE PATIENT. THE BALLOON WAS ALL MANGLED. THE ISSUE FOUND DURING A THERAPEUTIC PROCEDURE. THERE WAS DELAY IN THE PROCEDURE WITH UNKNOWN TIME. THERE WAS NO PATIENT HARM OR INJURY REPORTED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980597 ↗