Olympus BD-400P-2080Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00821925033214), received between Feb 1, 2021 and Jul 30, 2026 — classified as 10 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (19 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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-0938-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Failure to Deflate

  It was reported that during a therapeutic EGD (esophagogastroduodenoscopy) the balloon only partially deflated. Attempts to remove the balloon both through the scope and simultaneously with the scope was met with resistance. There was an injury to the esophagus with mid to moderate amount of bleeding which required clipping. After the scope was removed from the patient, the balloon was removed without being cut and it was noted that the balloon was bunched at the end. The reported event resulted in a procedural prolongation of less than 30 minutes.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 50083150 ↗
• MalfunctionNov 13, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550837 ↗
• InjuryJul 14, 2025Detachment of Device or Device Component; Failure to Deflate; Detachment of Device or Device Component; Failure to Deflate

  IT WAS REPORTED UPON THE COMPLETION OF AN ESOPHAGOGASTRODUODENOSCOPY (ESG), THE USER WAS UNABLE TO DEFLATE THE SUBJECT DEVICE. THE USER HAD TO CUT THE BALLOON TO REMOVE IT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22493144 ↗
• MalfunctionJul 7, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED DURING A THERAPEUTIC UPPER ENDOSCOPY PROCEDURE; THEY WERE NOT ABLE TO DEFLATE THE BALLOONS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420133 ↗
• MalfunctionOct 14, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THE BALLOON DIALATOR COULD NOT BE DEFLATED AND BECAME STUCK INSIDE THE SCOPE CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439378 ↗
• MalfunctionJun 24, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THE SINGLE-USE BALLOON INFLATOR EXPERIENCED AN OUT OF BOX FAILURE IN WHICH THE BALLOON WAS ALREADY INFLATED AND COULD NOT PASS THROUGH THE ENDOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593504 ↗
• MalfunctionMar 12, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED, THAT THE BALLOON BURST WHEN INFLATED. THE ISSUE WAS FOUND DURING THE DIAGNOSTIC ENDOSCOPY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889315 ↗
• MalfunctionJan 17, 2024

  INFLATION BALLOON WOULD NOT DEFLATE ENOUGH TO BE REMOVED FROM THE SCOPE. USED THE PUMP TO DEFLATE- IT WENT DOWN BUT NOT ENOUGH TO BE REMOVED FROM THE SCOPE. DISCONNECTED THE PUMP AND CONNECTED A SYRINGE AND TRIED TO REMOVE ANY WATER. TRIED TO REMOVE THE BALLOON AGAIN AND IT WOULD NOT BUDGE. HAD TO REMOVE SCOPE AND CUTTERS TO CUT IN 1/2 TO GET THE EQUIPMENT OUT OF THE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525982 ↗
• MalfunctionDec 15, 2023Deflation Problem; Deflation Problem

  THE OLYMPUS FIELD CORRECTIVE ACTION ADMINISTRATOR REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE BALLOON DOES NOT DEFLATE WELL, THEREFORE WAS UNABLE TO PULL THE BALLOON OUT WHILE USING THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE. IT WAS NOTED THAT TO PULL OUT THE BALLOON, THE ENTIRE ENDOSCOPE WAS WITHDRAWN FROM THE PATIENT THEN THE BALLOON PART WAS CUT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18338648 ↗
• MalfunctionDec 14, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE EZDILATE BALLOON DILATOR FOR A THERAPEUTIC PROCEDURE, THE USER WAS UNABLE TO PULL THIS DEVICE FROM THE SCOPE AFTER IT WAS DILATED. THE ISSUE OCCURRED AT THE END OF THE CASE. THE PROCEDURE DID NOT NEED TO BE PROLONGED, AND PATIENT¿S ANESTHESIA OR SEDATION WAS NOT EXTENDED. PROCEDURE WAS COMPLETED BY CUTTING THE BALLOON FROM THE CATHETER TO REMOVE FROM THE SCOPE. THE ISSUE DID NOT AFFECT THE OUTCOME OF THE PROCEDURE AND NO MEDICAL INTERVENTIONS WERE REQUIRED. DEVICE CONNECTED TO SUBJECT DEVICE DURING MALFUNCTION WAS AN INFLATION DEVICE FOR ENDOSCOPIC BALLOON DILATATION MODEL# MAJ-1740. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6), (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332436 ↗
• MalfunctionDec 7, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  RELATED PATIENT IDENTIFIERS: (B)(6) BD-400P-2080 SN (B)(6 (B)(3) (B)(6) 2023, (B)(6) BD-400P-2080 SN (B)(6) (B)(3) (B)(6) 2023, AND (B)(6) BD-400P-2080 SN UNKNOWN (B)(3) (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18284284 ↗
• MalfunctionDec 7, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE EZDILATE BALLOON DILATOR FOR A THERAPEUTIC PROCEDURE, THE USER WAS UNABLE TO PULL THIS DEVICE FROM THE SCOPE AFTER IT WAS DILATED. THE ISSUE OCCURRED AT THE END OF THE CASE. THE PROCEDURE DID NOT NEED TO BE PROLONGED, AND PATIENT¿S ANESTHESIA OR SEDATION WAS NOT EXTENDED. PROCEDURE WAS COMPLETED BY CUTTING THE BALLOON FROM THE CATHETER TO REMOVE FROM THE SCOPE. THE ISSUE DID NOT AFFECT THE OUTCOME OF THE PROCEDURE AND NO MEDICAL INTERVENTIONS WERE REQUIRED. DEVICE CONNECTED TO SUBJECT DEVICE DURING MALFUNCTION WAS AN INFLATION DEVICE FOR ENDOSCOPIC BALLOON DILATATION MODEL# MAJ-1740. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18284228 ↗
• MalfunctionNov 22, 2023Infusion or Flow Problem; Infusion or Flow Problem

  ON BEHALF OF THE CUSTOMER, AN OLYMPUS REPRESENTATIVE REPORTED THE FACILITY HAD ISSUES DURING DEFLATION OF THE BALLOON, THE BALLOON GOT CAUGHT ON THE CATHETER AND HAD TO BE CUT OFF. THE EVENT OCCURRED DURING A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. INSPECTION AND TESTING OF THE RETURNED DEVICE REVEALED UNSUCCESSFUL BALLOON INFLATION. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194523 ↗
• MalfunctionOct 27, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EZDILATE BALLOON DILATOR (FW) 18-19-20 BALLOONS ARE NOT DEFLATING. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019838 ↗
• MalfunctionOct 17, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON WOULD NOT DEFLATE ALL THE WAY AFTER ALL ATTEMPTS WERE MADE. THE ISSUE OCCURRED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY PROCEDURE. THE PROCEDURE WAS DELAYED BY 2 MINUTES AND WAS COMPLETED WITHOUT HARM OR INJURY TO THE PATIENT. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949741 ↗
• MalfunctionOct 4, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EZDILATE BALLOON DILATOR (FW) 18-19-20 DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE THE BALLOON BURST/RUPTURED WHILE INSIDE A PATIENT. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE DEVICE WAS DISCARDED AFTER USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867624 ↗
• MalfunctionAug 29, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON DID NOT DEFLATE COMPLETELY AND GOT STUCK IN THE SCOPE WHILE WITHDRAWING IT FROM THE SCOPE. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ESOPHAGEAL DILATION PROCEDURE. REPORTEDLY, THE BALLOON WAS CUT FROM THE SCOPE, BUT DILATION WAS COMPLETED FIRST. THE REPORTED ISSUE DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646949 ↗
• MalfunctionAug 24, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE BALLOON POPPED DURING A THERAPEUTIC ESOPHAGEAL DILATION PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619815 ↗
• MalfunctionAug 24, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON DID NOT DEFLATE COMPLETELY AND GOT STUCK IN THE SCOPE WHILE WITHDRAWING IT FROM THE SCOPE. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ESOPHAGEAL DILATION PROCEDURE. REPORTEDLY, THE BALLOON WAS CUT FROM THE SCOPE, BUT DILATION WAS COMPLETED FIRST. THE REPORTED ISSUE DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619512 ↗
• MalfunctionAug 24, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON DID NOT DEFLATE COMPLETELY AND GOT STUCK IN THE SCOPE WHILE WITHDRAWING IT FROM THE SCOPE. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ESOPHAGEAL DILATION PROCEDURE. REPORTEDLY, THE BALLOON WAS CUT FROM THE SCOPE, BUT DILATION WAS COMPLETED FIRST. THE REPORTED ISSUE DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619361 ↗
• MalfunctionAug 22, 2023Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT WHEN USING AN EZ DILATE BALLOON DILATOR (FW) 18-19-20, THE BALLOON GOT STUCK IN THE ENDOSCOPE AND NEEDED TO BE CUT TO REMOVE IT. THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (UPPER GI ENDOSCOPY) AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS LINKED TO PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597752 ↗
• MalfunctionAug 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT WHEN USING AN EZ DILATE BALLOON DILATOR (FW) ON (B)(6) 2020, THE BALLOON GOT STUCK IN THE ENDOSCOPE AND NEEDED TO BE CUT TO REMOVE IT. THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (UPPER GI ENDOSCOPY) AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS ABOUT A FIVE-MINUTE DELAY AND NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE REPORT IS LINKED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17589067 ↗
• MalfunctionAug 17, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE BALLOON FAILED DURING A DIAGNOSTIC ESOPHAGEAL DILATION PROCEDURE. REPORTEDLY, THE BALLOON DID NOT FULLY DEFLATE. THE DOCTOR WAS ABLE TO RETRIEVE THE WHOLE BALLOON, AFTER REMOVING THE SCOPE FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITHOUT A DELAY. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568519 ↗
• MalfunctionAug 16, 2023Burst Container or Vessel; Burst Container or Vessel

  THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE (MAC) DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558797 ↗
• MalfunctionAug 14, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER CONFIRMED THE PATIENT DID NOT REQUIRE ADDITIONAL ANESTHESIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PROCEDURE WAS PRACTICALLY ENDED WHEN THE DEVICE MALFUNCTIONED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE MALFUNCTION. THIS DEVICE MALFUNCTION DID NOT AFFECT PATIENT OUTCOMES. NO OTHER DEVICES USED DURING THE EVENT THAT COULD HAVE CONTRIBUTED TO THE MALFUNCTION. OTHER RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541311 ↗