Boston Scientific Corporation Recall 95124
Description: WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered 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): M00516720
Boston Scientific Corporation Recall 95124 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3277-2024 |
| Event ID | 95124 |
| Event Description | WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered 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): M00516720 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM. |
| Quantity | 79 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: 08714729778059 Lot Numbers: 32770266, 32780362, 32865975, 32906417, 32975732, 33017656, 33128876, 33167135 |
| Center Classification Date | 20240926 |
| Recall Initiation Date | 20240801 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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