Skip to content

Olympus BD-400P-0880Recalls & reported problems

Gyrus ACMI, LLC · EZDilate - Fixed Wire Esophageal 3-Stage Balloon Dilatation Catheter 6-8-mm · Class 2

All models of Olympus (27)

Data updated Oct 16, 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
2
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925033160), received between Jun 2, 2022 and Aug 29, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 16, 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-0933-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Perforation of Esophagus1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 29, 2022Material Rupture; Material Rupture

    OLYMPUS WAS NOTIFIED OF AN OUT OF BOX FAILURE FOR ONE BD-400P-0880 BALLOON. WHILE THE BALLOON WAS INSIDE THE PATIENT, THE CUSTOMER INFLATED THE BALLOON TO 6MM AND THE BALLOON RUPTURED INSIDE THE PATIENT. THE RUPTURED BALLOON WAS RETRIEVED FROM INSIDE THE PATIENT AND THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH A SECOND BD-400P-0880. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15311229 ↗
  • InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE "CASE REPORT ENDOSCOPIC TISSUE SHIELDING WITH POLYGLYCOLIC ACID SHEET, FIBRIN GLUE,AND ENDOCLIP FOR PERFORATION DURING BALLOON DILATION FOR ESOPHAGEAL STRICTURE AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION."     LITERATURE SUMMARY: ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION CAN CAUSE ESOPHAGEAL STRICTURES. ENDOSCOPIC BALLOON DILATION IS THE STANDARD TREATMENT FOR ESOPHAGEAL STRICTURES, BUT HAS COMPLICATIONS, INCLUDING PERFORATION, AND SOMETIMES REQUIRES SURGERY. WE REPORT A CASE OF PERFORATION DURING ENDOSCOPIC BALLOON DILATION FOR ESOPHAGEAL STRICTURE SECONDARY TO ESOPHAGEAL SUBMUCOSAL DISSECTION THAT WAS SUCCESSFULLY TREATED CONSERVATIVELY. A 66-YEAR-OLD MAN WITH SUPERFICIAL CARCINOMA IN THE UPPER THORACIC ESOPHAGUS UNDERWENT CIRCUMFERENTIAL ENDOSCOPIC SUBMUCOSAL DISSECTION WITH LOCAL STEROID INJECTIONS. ENDOSCOPIC BALLOON DILATION WAS PERFORMED WEEKLY FOR ESOPHAGEAL STRICTURE. HOWEVER, DURING THE SIXTH PROCEDURE, AN ATTEMPT TO INCREASE THE SIZE OF THE BALLOON TO 13.5 MM RESULTED IN PERFORATION. THE PATIENT WAS TREATED CONSERVATIVELY USING POLYGLYCOLIC ACID SHEET WITH FIBRIN GLUE AT THE PERFORATION SITE, WHICH WAS FIXED USING AN ENDOCLIP. HOWE

    Patient problems: Perforation of Esophagus

    MAUDE report 14575398 ↗

Other Dilator, esophageal devices

All Dilator, esophageal devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page