Zilver 518 Biliary Stent recall issued due to incorrect instruction for use details
The FDA is recalling the Zilver 518 Biliary Stent because its instruction for use details were incorrect, requiring updated deployment guidance.
- Product
- Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
- Category
- Medical Device
- Distribution
- Distributed nationwide