Recall archive / FDA device enforcement
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna... — FDA record Z-0216-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 1, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SMART FLEX 9x60 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.
- Reason
- There is a potential for distal tip dislodgement or separation.
- Classification
- Class II
- Recalling firm
- Cordis Corporation
- Quantity
- 9 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0216-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Code: SF09060SB; Lot No. 253349 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 24, 2021
- Recall initiation date
- Oct 1, 2021
- Center classification date
- Nov 12, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.