Device product
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Z-0219-2022
Product summary
- Event
- Event 88821
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-0219-2022
Official wording
Reason: There is a potential for distal tip dislodgement or separation.
Code information: Product Code: SF08060SB; Lot No. 266523
Distribution pattern: US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
Derived failure modes
-
Unknown
There is a potential for distal tip dislodgement or separation.