FDA-Device2024-10-02Class II
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
Hazard
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Sold states
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Affected count
79 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3277-2024Don't want to check this manually?
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