Cordis recalls SMART Flex 10x100 BIL, 80cm biliary stent systems due to potential distal tip dislodgement. Affected units have product code SF10100SB.
There is a potential for distal tip dislodgement or separation.
Cordis is recalling SMART Flex 10x100 BIL, 80cm biliary stent systems because they may dislodge from the body. This could cause serious complications for patients needing stent placement.
The stent's distal tip could become dislodged from the biliary tract, potentially causing blockages or leaks. This may lead to infections or other complications in patients with cancer-related bile duct obstructions.
Patients who received this specific biliary stent system for cancer treatment are most at risk. Healthcare providers using the product for palliative care may also be affected.
Check for product code SF10100SB on the stent packaging. The stent is 80cm long and used for biliary tree palliation in cancer treatment.
Look for product code SF10100SB on the stent packaging or documentation.
The recall states there is a potential for distal tip dislodgement, but it does not specify that the stent is unsafe when used properly.
Check for product code SF10100SB on the stent packaging or documentation. The stent is 80cm long and used for biliary tree palliation in cancer treatment.
The recall does not specify a remedy, so contact Cordis directly for guidance.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0220-2022 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0220-2022 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.
