Cordis recalls SMART Flex 6x120 Biliary Stent Systems due to potential distal tip dislodgement. Affected units have product code SF06120MB and lot number 266401.
There is a potential for distal tip dislodgement or separation.
Cordis is recalling SMART Flex 6x120 Biliary Stent Systems that may dislodge from the body. This could cause complications for patients needing stent placement for biliary issues.
The stent's distal tip may become dislodged from the biliary tract, potentially causing blockages or leaks. This could lead to complications like infection or pain in patients needing stent placement for biliary issues.
Patients who have received the SMART Flex 6x120 Biliary Stent System for biliary stricture treatment are affected. Those with the product code SF06120MB and lot number 266401 are most at risk.
Check for product code SF06120MB and lot number 266401 on the stent system. The product is a SMART Flex 6x120 Biliary Stent System used for biliary stricture palliation.
Look for product code SF06120MB and lot number 266401 on the stent system.
The stent's distal tip may become dislodged from the biliary tract, potentially causing blockages or leaks.
Check for product code SF06120MB and lot number 266401. If you have these details, contact Cordis for guidance.
The recall record does not specify a remedy.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0217-2022 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0217-2022 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.
