medical Class II Updated 2024-10-02

Boston Scientific Corporation recalls AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Pa

Recalled Product

AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW 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): M00517760

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: 00191506006631 Lot Numbers: 33005085
View official government recall

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