Device evidence

device-recall:cfres:167924

Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

Official recall number

Z-0326-2019

Evidence summary

Product code: FGE
Recall status: Terminated
Event initiated: September 25, 2018
Root cause: Under Investigation by firm
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-0326-2019