Home › Device types › ESW
Prosthesis, Esophageal
FDA product code ESW · Class 2 · General, Plastic Surgery
1,042
Registered devices
3,094
Adverse events
67
Recalls
60
510(k) clearances
Devices with this code
HILZO Esophageal stents — BCM Co., Ltd.HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.Agile™ Esophageal — BOSTON SCIENTIFIC CORPORATIONHANAROSTENT® Esophagus (NCN) — M.I.Tech Co., Ltd.HILZO Esophageal stents — BCM Co., Ltd.HANAROSTENT® Esophagus TTS(CCC) — M.I.Tech Co., Ltd.Niti-S Esophageal Stent — TAEWOONGMEDICAL.CO.,LTDSegmented Esophageal Stent System — Micro-Tech (Nanjing) Co., Ltd.Esophageal TTS Stent — TAEWOONGMEDICAL.CO.,LTDHANAROSTENT® Esophagus TTS(NCN) — M.I.Tech Co., Ltd.Niti-S Esophageal Stent — TAEWOONGMEDICAL.CO.,LTDHILZO Esophageal stents — BCM Co., Ltd.HANAROSTENT® Esophagus TTS(NCN) — M.I.Tech Co., Ltd.Esophageal TTS Stent — TAEWOONGMEDICAL.CO.,LTDHANAROSTENT® Esophagus (CCC) — M.I.Tech Co., Ltd.ALIMAXX-ES™ — Merit Medical Systems, Inc.Niti-S Esophageal Stent — TAEWOONGMEDICAL.CO.,LTDHILZO Esophageal stents — BCM Co., Ltd.Esophageal TTS Stent — TAEWOONGMEDICAL.CO.,LTDHILZO Esophageal stents — BCM Co., Ltd.HILZO Esophageal stents — BCM Co., Ltd.HILZO Esophageal stents — BCM Co., Ltd.HILZO Esophageal stents — BCM Co., Ltd.HILZO Esophageal stents — BCM Co., Ltd.
Recent 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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