HANAROSTENT® Esophagus TTS(CCC) ECBA-20-080-180Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08806367088444), received between Oct 5, 2023 and Oct 5, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2023Fracture; Fracture
AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, A HANAROSTENT ESO TTS FC 20 DM 8CM 180, FRACTURED IN HALF INSIDE OF THE PATIENT SEVERAL WEEKS POST-IMPLANTATION. THE PHYSICIAN USED THE STENT OFF-LABEL SINCE THERE WERE NO STENTS DESIGNED FOR THE THERAPEUTIC PROCEDURE (GASTRIC BYPASS POUCH STENTING) PERFORMED. THE PATIENT WAS ABLE TO EAT NORMALLY FOR SEVERAL WEEKS POST-PROCEDURE, THEN DEVELOPED POST-OPERATIVE PAIN AND FOLLOWED UP WITH THE PHYSICIAN. IT WAS THEN DISCOVERED THAT THE STENT WAS FRACTURED IN HALF. THE PATIENT RETURNED FOR A PROCEDURE TO RETRIEVE THE BROKEN STENT, WHICH WAS RETRIEVED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY OR HARM. FLUOROSCOPIC AND ENDOSCOPIC IMAGES CONFIRMED THE ENTIRE STENT WAS RETRIEVED.
Patient problems: Pain
MAUDE report 17877147 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page