Olympus BD-400P-1880Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00821925033207), received between May 19, 2022 and Sep 8, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674468 ↗
• MalfunctionAug 31, 2026Break

  No additional information received from the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523889 ↗
• MalfunctionAug 25, 2026Failure to Deflate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436561 ↗
• MalfunctionJun 30, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A THERAPEUTIC UPPER ENDOSCOPY PROCEDURE, THE BALLOON OF THE SUBJECT DEVICE WAS NOT ABLE TO DEFLATE AND HAD TO BE CUT IN ORDER TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367344 ↗
• MalfunctionMay 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THE SUBJECT DEVICE BALLOON DEFLATED POORLY AND COULD NOT BE REMOVED FROM THE SCOPE. THIS ISSUE OCCURRED DURING A UNKNOWN THERAPEUTIC PROCEDURE AND WAS COMPLETED BY REMOVING THE SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078423 ↗
• MalfunctionDec 5, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE FULLY AND WAS SUCKED INTO THE SCOPE. THE ISSUE OCCURRED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, WITH A NOTED DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857183 ↗
• MalfunctionOct 16, 2024Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  THE CUSTOMER LATER REPORTED THAT WHILE DILATING THE ESOPHAGUS FOR A STRICTURE, THE BALLOON WAS INFLATED TO 16 MM AND RUPTURED. THE ISSUE OCCURRED DURING THE MIDDLE OF A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE BALLOON WITH A 2-3 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461424 ↗
• MalfunctionOct 9, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THE EZDILATE BALLON DILATOR COULD NOT BE DEFLATED AND BECAME STUCK INSIDE THE SCOPE CHANNEL. IT IS UNSPECIFIED WHEN THIS ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407063 ↗
• MalfunctionOct 8, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THE BALLOON DILATOR COULD NOT BE DEFLATED AND BECAME STUCK INSIDE THE SCOPE CHANNEL. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396940 ↗
• MalfunctionJul 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE EZDILATE BALLOON DILATOR HAD BURST/RUPTURE. IT IS UNKNOWN WHEN THE DIAGNOSTIC ENDOSCOPY PROCEDURE WAS PERFORMED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725868 ↗
• MalfunctionNov 18, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON BROKE AND ANOTHER SCOPE AND ANOTHER BALLOON HAD TO BE USED TO COMPLETE THE ESOPHAGEAL DILATION PROCEDURE. THIS CAUSED A 10 MINUTE DELAY BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT IMPACT TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166770 ↗
• MalfunctionNov 12, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED TO OLYMPUS, AN OUT OF BOX FAILURE. THE EZDILATE BALLOON DILATOR EXPLODED AT 4CM. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117437 ↗
• MalfunctionNov 9, 2023Burst Container or Vessel; Burst Container or Vessel

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EZDILATE BALLOON DILATOR (FW) 16-17-18 BURST WHILE DILATING IN THE PATIENT. THIS OCCURRED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) ESOPHAGEAL DILATION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099800 ↗
• MalfunctionAug 7, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING AN EZ DILATE BALLOON DILATOR, IT WOULD NOT DEFLATE PROPERLY. THIS HAS HAPPENED ON MORE THAN ONE OCCASION. THE EVENT OCCURRED DURING THE PROCEDURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS LINKED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470512 ↗
• MalfunctionJul 27, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED TO OLYMPUS, THE EZDILATE BALLOON DILATOR WOULD NOT DEFLATE PROPERLY. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410302 ↗
• MalfunctionJul 5, 2023Crack; Deflation Problem; Crack; Deflation Problem

  NO ERROR MESSAGES THAT MAY HAVE BEEN OBSERVED BECAUSE OF THE FAILURE. THE PROCEDURE WAS THERAPEUTIC AND THE PROBLEM MINIMALLY PROLONGED THE PROCEDURE BUT DID NOT AFFECT OUTCOME OR PATIENT. NO MEDICAL INTERVENTION NEEDED. THE OLYMPUS INFLATION DEVICE SYRINGE WAS CONNECTED TO THE BALLOON AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260785 ↗
• MalfunctionFeb 10, 2023Break; Break

  IT WAS REPORTED DURING DILATION PROCEDURE , THE 16-17-18MM (BD-400P-1880) DILATATION BALLOON BROKE. ACCORDING TO THE REPORT, THE NURSE USED OLYMPUS INFLATION HANDLE AS INSTRUCTED IN IFU, THE BALLOON FILLED WITH OUT A PROBLEM TO 16MM AND 17MM. WHEN STARTING TO FILL TO 18MM THE BALLOON SUDDENLY BROKE INSIDE THE PATIENTS ESOPHAGUS. A NEW 16-17-18MM BALLOON WAS THEN USED TO PERFORM THE DILATION PROCEDURE WITHOUT ANY PROBLEM. NO EXCESS FORCE HAD BEEN NEEDED WHEN INSERTING THE BALLOON THROUGH THE SCOPE. NO RIFTS OR TARES WERE VISIBLE WHEN INSPECTED BEFORE USE. OLYMPUS SINGLE USE INFLATION DEVICE FOR EZDILATE WAS USED (EGMAJ-1740) WHEN PROCEDURE WAS PERFORMED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358499 ↗
• MalfunctionSep 9, 2022Material Rupture; Material Rupture

  AN OLYMPUS REPRESENTATIVE CONTACTED THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), TO REPORT A BALLOON POP UPON INFLATION DURING A ESOPHAGEAL DILATION PROCEDURE. FURTHER INQUIRY WITH CUSTOMER REVEALED THE BALLOON POPPED BUT DIDN¿T FALL INTO PATIENT. IT WAS STILL ATTACHED TO THE CATHETER AND PULLED THROUGH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT DELAY. THERE WAS NO PATIENT INJURY OR HARM DUE TO THE DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391117 ↗
• InjuryAug 24, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED DURING AN UNKNOWN PROCEDURE, THE BALLOON WAS INFLATED TO 18MM AND IT RUPTURED INSIDE THE PATIENT. THE BALLOON FRAGMENTS WERE REMOVED FROM THE PATIENT WITH AN UNKNOWN INSTRUMENT 'TO THE BEST OF THEIR KNOWLEDGE.' MULTIPLE ATTEMPTS REQUESTING ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 15287688 ↗
• MalfunctionMay 19, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT AN ULTRASOUND BALLOON WOULD NOT DEFLATE DURING A CASE. ACCORDING TO THE REPORTER, TWO (2) DIFFERENT BALLOONS WERE USED IN THE SAME CASE, BUT WITH THE SAME ISSUE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (FIRST BALLOON).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14447266 ↗