Device evidence

device-recall:cfres:193884

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

Official recall number

Z-1363-2022

Evidence summary

Product code: FGE
Recall status: Open, Classified
Event initiated: May 20, 2022
Root cause: Process design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1363-2022