FDA Device recall Z-0221-2022
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th…
- FDA Device
- Class II
- ongoing
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in th… by Cordis, citing there is a potential for distal tip dislodgement or separation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0221-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-01 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cordis |
| Distribution | CA, FL, IN, LA, OH, OK, TX |
Product
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Reason
There is a potential for distal tip dislodgement or separation.
Identifiers
| code_info | Product Code: SF10100MB; Lot No. 271626 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0221-2022%22
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