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.
There is a potential for distal tip dislodgement or separation.
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.
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.
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.
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.
Identify the product code (SF06150MB) and lot numbers (266415, 266417, 266419) to confirm if your stent is affected.
The stent's distal tip may become dislodged, potentially causing blockages or complications in the biliary system.
Product code SF06150MB and lot numbers 266415, 266417, and 266419.
The recall does not require immediate discontinuation; however, affected units should be checked for the specific product codes and lot numbers.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0218-2022 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0218-2022 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.
