medical Class II Updated 2020-09-23

Boston Scientific Corporation recalls WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx6

Recalled Product

WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.

Hazard / Issue

Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot code:25607019 Exp. Date: June 17th , 2022 GIN:08714729953180
View official government recall

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