medical Class II Updated 2024-10-02

Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Par

Recalled Product

WALLFLEX FC ESO STENT RMV LL 23X155- 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): M00516320

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: 08714729905578 Lot Numbers: 32753933, 32937357, 32987960, 33218763
View official government recall

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