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Esophageal Stent System
Micro-Tech (Nanjing) Co., Ltd. · Model NST01-224-22.150 · UDI-DI 06932503580366
ESW
Prescription
1
510(k) clearances
3,094
Adverse events (130 deaths)
67
Recalls
31
Facilities
Description
Double cup 22×150,fully covered stent with 6.7mm outer sheath,650mm working length delivery 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.