Cordis recalls SMART Flex 8x6:60 BIL stents 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 8x60 BIL biliary stents because they may become dislodged, causing blockages. This could lead to serious complications if the stent moves inside the body.
The stent's distal tip may become dislodged during use, potentially blocking the bile duct. This could cause pain, infection, or other complications if the stent moves inside the body.
Patients with biliary stents who received the SMART Flex 8x60 BIL model from Cordis. Those with malignant biliary strictures are most at risk.
Check for the product code SF08060SB on the stent packaging. The stent is used for treating malignant biliary strictures and was sold with lot number 266523.
Reach out to Cordis Corporation for guidance on next steps.
Yes, there is a potential for the stent tip to become dislodged, which could cause blockages or complications.
Contact Cordis Corporation for specific instructions on how to proceed.
Look for the product code SF08060SB on the packaging or check the lot number 266523.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0219-2022 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0219-2022 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.
