Z-3291-2024 Class II Ongoing
FDA device recall Z-3291-2024 was initiated by Boston Scientific Corporation on Aug 1, 2024 and is designated Class II. Reason for recall: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. The recall status is ongoing. Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 2, 2024
- Initiation Date
- Aug 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
AGILE ESO OTW FC 23MM X 10.1CM 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): M00517760
Reason for Recall
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Code Information
GTIN: 00191506006631 Lot Numbers: 33005085
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3291-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026