Boston Scientific Corporation Recall 95124
Description: AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517710
Boston Scientific Corporation Recall 95124 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3287-2024 |
| Event ID | 95124 |
| Event Description | AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517710 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM. |
| Quantity | 6 units |
| Recall Reason | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Device Classification | 20241002 |
| Device Code Info | GTIN: 00191506006587 Lot Numbers: 33178843 |
| Center Classification Date | 20240926 |
| Recall Initiation Date | 20240801 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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