HANAROSTENT® Esophagus TTS(CCC) ECBA-18-060-180Recalls & 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 08806367088208), received between Aug 23, 2024 and Aug 23, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Gastrointestinal Hemorrhage1
- Retroperitoneal Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY FOR BENIGN GASTRIC OUTLET OBSTRUCTION (GOO): A RETROSPECTIVE ANALYSIS OF PATIENTS AND OUTCOMES". LITERATURE SUMMARY BACKGROUND AND STUDY AIMS ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY (EUS-GJ) HAS BEEN WELL UTILIZED IN TREATING MALIGNANT GASTRIC OUTLET OBSTRUCTIONS (GOO) GIVEN ITS EFFICACY AND LOWER RISK PROFILE COMPARED TO SURGERY. HOWEVER, ITS EFFICACY AND POTENTIAL FOR USE IN PATIENTS WITH BENIGN GOO WHO ARE POOR SURGICAL CANDIDATES IS NOT WELL DOCUMENTED. THE AIM OF THIS STUDY WAS TO EXAMINE THE ROLE OF EUS-GJ IN TREATMENT OF BENIGN GOO IN SELECT PATIENTS. PATIENTS AND METHODS THIS IS A SINGLE-CENTER, OPEN-LABEL, RETROSPECTIVE DESCRIPTIVE STUDY THAT INCLUDED ALL CONSECUTIVE PATIENTS UNDERGOING EUS-GJ TO TREAT BENIGN CAUSES OF GOO. DIRECT ANTEGRADE AND DIRECT RETROGRADE METHODS WERE UTILIZED. RESULTS A TOTAL OF 18 PATIENTS WERE INCLUDED, 38.9% FEMALE WITH AN AVERAGE AGE OF 63.3 YEARS. EXTRINSIC GOO WAS PRESENT IN (10 OF 18) 55.5% OF PATIENTS AND INTRINSIC ETIOLOGY WAS PRESENT IN (8 OF 18) 45.5% OF PATIENTS. TECHNICAL SUCCESS WAS ACHIEVED IN 100% (18 OF 18) PATIENTS AND CLINICAL
Patient problems: Gastrointestinal Hemorrhage; Retroperitoneal Hemorrhage
MAUDE report 20048209 ↗
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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