Cordis recalls SMART Flex 9x6:80cm biliary stent systems due to potential distal tip dislodgement. Affected patients should contact for guidance.
There is a potential for distal tip dislodgement or separation.
Cordis is recalling SMART Flex 9x60 BIL, 80cm biliary stent systems because they may dislodge from the body. This could cause serious complications if the stent moves unexpectedly.
The stent tip could become dislodged from the biliary tract, potentially causing blockages or leaks. This may lead to infections or other complications if the stent moves unexpectedly.
Patients with malignant biliary strictures who received this stent system are affected. Those with the specific product code SF09060SB are most at risk.
Check for the product code SF09060SB on the stent packaging. The stent is used for treating malignant biliary strictures and sold with the model name SMART Flex 9x60 BIL, 80cm.
Reach out to Cordis Corporation for specific guidance on your stent system.
The recall states there is a potential for distal tip dislodgement, which could cause complications. However, the stent is designed for palliation of malignant strictures.
Check for the product code SF09060SB on the packaging or documentation.
Contact Cordis Corporation directly for instructions on next steps.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0216-2022 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0216-2022 from Cordis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
