medical Class II Updated 2024-10-02

Boston Scientific Corporation recalls WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal

Recalled Product

WALLFLEX PC ESOPH STENT 23/28MM X 125MM- 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): M00516940

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: 08714729765288 Lot Numbers: 32759900, 32759903, 32789717 32789718, 32829629, 32847692 32848481, 32898067, 32919347 32927195, 32949480, 32956257 32957302, 32965072, 32985475 32987961, 33047928, 33145976 33145978, 33208046, 33208048 33242626, 33275535
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