medical Class II Updated 2024-10-02

Boston Scientific Corporation recalls WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Part

Recalled Product

WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-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): M00516750

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: 08714729778080 Lot Numbers: 32809369, 32809370, 32820234 ,32829719, 32837015, 32859849, 32888837, 32888838, 32914768, 32919658, 32919659, 32938991 32956256, 32977683, 32980850, 32986659, 32994875, 32998177, 33014830, 33101458, 33119730, 33176329, 33195046, 33195048 33208043, 33208044, 33218761, 33242625, 33266646, 33266649
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