medical Class II Updated 2024-10-02

Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintainin

Recalled Product

WALLFLEX FC ESO STENT RMV LL 23X105- 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): M00516300


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: 08714729905554 Lot Numbers: 32771052, 32846905
View official government recall

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