HANAROSTENT® Esophagus TTS(CCC) ECBA-20-060-180Recalls & reported problems
M.I.Tech Co., Ltd. · Full Covered metallic esophagus stent · Class 2 · Implant
- 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 08806367088406), received between Jul 7, 2026 and Jul 7, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THIS SELF-EXPANDING METALLIC ESOPHAGEAL STENT WAS USED AS OFF-LABEL IN THE DUODENUM. THE STENT WAS SUTURED INTO THE DUODENUM AND WHEN THE PATIENT CAME IN FOR CT SCAN FOLLOW UP, IT WAS FOUND THAT THE STENT HAD RIPPED AWAY FROM THE SUTURES AND SPLIT IN HALF. ADDITIONAL INFORMATION WAS RECEIVED THAT ADDITIONAL SURGERY WAS DONE TO REMOVE BOTH HALVES FROM THE SMALL BOWEL. SUBSEQUENT IMAGING CONFIRMED THE STENT'S REMOVAL. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 25737133 ↗
Other Prosthesis, Esophageal devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.