medical Class II Updated 2024-10-02

Boston Scientific Corporation recalls WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal

Recalled Product

WALLFLEX PC ESOPH STENT 18/23MM X 153MM- 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): M00516920


Hazard / Issue

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 08714729765264 Lot Numbers: 32965060, 33077153, 33120914, 33266650
View official government recall

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