Cordis SMART Flex Biliary Stent System Recall: Risk of Stent Dislodgement
Cordis recalls SMART Flex 6x150 BIL, 120cm biliary stent systems with potential for distal tip dislodgement. Affected units have specific product codes and lot numbers.
Use caution until it’s fixed
There is a potential for distal tip dislodgement or separation.
Contact the company
What happened, in plain English
Cordis is recalling SMART Flex 6x150 BIL, 120cm biliary stent systems due to a risk that the stent tip could become dislodged. This could lead to complications in patients with biliary tree strictures. Read more at govinfonow.com/recall/61721-cordis-smart-flex-biliary-stent-system-recall-risk-of-stent.
Source Summary by GovInfoNow · govinfonow.com/recall/61721-cordis-smart-flex-biliary-stent-system-recall-risk-of-stent · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0218-2022
Cite this page
“Cordis SMART Flex Biliary Stent System Recall: Risk of Stent Dislodgement.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61721-cordis-smart-flex-biliary-stent-system-recall-risk-of-stent. Based on FDA recall #Z-0218-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0218-2022%22&limit=1).
Why it’s dangerous
The stent's distal tip may become dislodged during use, potentially causing blockages or complications in the biliary system. This risk is specific to the design of the stent in certain patients.
Who’s affected
Patients who have received the SMART Flex 6x150 BIL, 120cm biliary stent system for biliary tree strictures. Those with the specific product codes and lot numbers are most at risk.
How to tell if you have this one
Check for product code SF06150MB and lot numbers 266415, 266417, or 266419 on the packaging. The stent system is used for palliating malignant strictures in the biliary tree.
- Brand
Cordis- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0216-2022 | 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.; Product Code: SF09060SB; Lot No. 253349 | 9 units |
| Z-0217-2022 | SMART FLEX 6x120 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.; Product Code: SF06120MB; Lot No. 266401 | 3 units |
| Z-0218-2022 | SMART FLEX 6x150 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.; Product Code: SF06150MB; Lot No. 266415, 266417, and 266419 | 26 units |
| Z-0219-2022 | 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.; Product Code: SF08060SB; Lot No. 266523 | 4 units |
| Z-0220-2022 | SMART FLEX 10x100 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.; Product Code: SF10100SB; Lot No. 266586 | 4 units |
| 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 the biliary tree.; Product Code: SF10100MB; Lot No. 271626 | 4 units |
What to do — step by step
Check Product Details
Identify the product code (SF06150MB) and lot numbers (266415, 266417, 266419) to confirm if your stent is affected.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
FDA distribution: “US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Indiana, Louisiana, Ohio, Oklahoma, Texas.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the stent immediately?
The recall does not require immediate discontinuation; however, affected units should be checked for the specific product codes and lot numbers.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0218-2022 (October 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0218-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.