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Boston Scientific Corporation recalls WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende
Recalled October 2, 2024 · FDA recall Z-3281-2024 · Boston Scientific
Hazard
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. · FDA Class II
Units
297 units
Sold at
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Description
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered 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): M00516900
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →