Home › M.I.Tech Co., Ltd. › HANAROSTENT® Esophagus Upper (CCC)
HANAROSTENT® Esophagus Upper (CCC)
M.I.Tech Co., Ltd. · Model ECP20130-X070 · UDI-DI 08809867585208
ESW
Prescription
1
510(k) clearances
3,094
Adverse events (130 deaths)
67
Recalls
31
Facilities
Description
Full Covered metallic esophagus stent
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| 2024-08-01 | Boston Scientific Corporation | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.