FDA Enforcement
Class II
Ongoing
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-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): M00517740
Recall: Z-3290-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3290-2024
- Event ID
- 95124
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- August 1, 2024
- Classification Date
- September 26, 2024
- Address
- 100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States
Description
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-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): M00517740
Reason
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Code Info
GTIN: 00191506006617 Lot Numbers: 33005084
Distribution
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Quantity
18 units