Cordis recalls SMART Flex 10x100 BIL, 120cm 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 10x100 BIL, 120cm biliary stent systems because there's a risk of the stent tip becoming dislodged. This could lead to complications in patients with biliary tract issues.
The stent's distal tip could become dislodged during use, potentially causing blockages or complications in the biliary tract. This is a risk in patients with malignant strictures where the stent is used for palliation.
Patients with biliary tract cancer who have received this stent system are most at risk. The recall affects specific models sold for palliation of malignant strictures.
Check for the product code SF10100MB and lot number 271626 on the stent system. This model was sold for palliation of biliary tract strictures.
Reach out to Cordis Corporation for guidance on next steps.
The recall states there is a potential for distal tip dislodgement, which could cause complications in patients with biliary tract issues.
Contact Cordis Corporation for specific instructions as the recall remedy is not stated in the record.
Look for product code SF10100MB and lot number 271626 on the stent system.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0221-2022 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0221-2022 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.
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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.
