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Esophageal TTS Stent
TAEWOONGMEDICAL.CO.,LTD · Model EST1810F · UDI-DI 08809744975504
ESW
Prescription
3
510(k) clearances
3,094
Adverse events (130 deaths)
67
Recalls
31
Facilities
Description
Fully Covered Esophageal Stent System
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. |
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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.