FDA-Device2024-10-02Class II
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System 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): M00516240
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
146 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System 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): M00516240
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3268-2024More Boston Scientific Corporation recalls
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