HANAROSTENT® Esophagus TTS(CCC) ECBA-20-120-180Recalls & reported problems
M.I.Tech Co., Ltd. · Full Covered metallic esophagus stent · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08806367088529), received between Jul 28, 2023 and Dec 11, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Perforation1
- Pneumoperitoneum1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2025Break; Break
OLYMPUS SALES REPRESENTATIVE (B)(4) REPORTED THE EVENT ON BEHALF OF THE TREATING PHYSICIAN, DOCTOR (B)(6). ACCORDING TO THE REPORT, AN ESOPHAGEAL STENT WAS IMPLANTED IN THE PATIENT'S DUODENUM IN (B)(6) 2024. THE PATIENT RETURNED TO THE HOSPITAL IN (B)(6) 2025, AT WHICH TIME A CT SCAN REVEALED THAT THE IMPLANTED STENT HAD FRACTURED INTO TWO PIECES, RESULTING IN SURGERY TO REMEDY THE ISSUE. THE EXACT TIME POINT WHEN THE STENT SPLIT INTO TWO PIECES WAS NOT IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23775589 ↗InjuryDec 11, 2025Break; Break
THE CUSTOMER (B)(6) REPORTED TO OLYMPUS REPRESENTATIVE (B)(6) THAT THE ECBA-20-100-180 HANARO STENT WAS PLACED IN THE PATIENT ON MARCH 1 AND FRACTURED AND BROKE APART IN THE PATIENT. THE DOCTOR RETRIEVED BOTH PIECES FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23775586 ↗InjuryJul 28, 2023Migration; Migration
AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THE HANAROSTENT WAS IMPLANTED IN THE ESOPHAGUS OF THE PATIENT, MIGRATED INTO THE STOMACH AND CAUSED A PNEUMOPERITONEUM. DR. (B)(6) HAD ALSO FOUND A PERFORATION IN THE STOMACH AND HE CLOSED IT OFF WITH TWO CLIPS. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: Perforation; Pneumoperitoneum
MAUDE report 17413676 ↗
Other Prosthesis, Esophageal devices
- WallFlex™ Esophageal M00516730Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall29 reports
- WallFlex™ Esophageal M00516740Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death22 reports
- WallFlex™ Esophageal M00516750Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall1 death19 reports
- WallFlex™ Esophageal M00516700Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall18 reports
- WallFlex™ Esophageal M00516910Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall15 reports
- WallFlex™ Esophageal M00516930Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall14 reports
- WallFlex™ Esophageal M00516710Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall13 reports
- WallFlex™ Esophageal M00516940Boston Scientific Corporation · PROSTHESIS, ESOPHAGEAL1 recall12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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