Cook Medical recalls Zilver 518 Biliary Stent 5mm x 20mm (ZIB5-125-5.0-20) due to incorrect deployment instructions in the user manual. This may affect safe use during medical procedures.
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
Cook Medical is recalling a specific biliary stent model because the instructions for removing the delivery system during deployment are incorrect. This could lead to improper stent placement if the user follows outdated instructions.
The recall addresses a technical error in the instructions for removing the delivery system during stent deployment. Incorrect procedures could lead to improper stent placement, but the hazard is not described as causing serious injury in normal use.
Patients receiving biliary stent procedures from Cook Medical. Medical professionals using the Zilver 518 stent during palliative treatments are most at risk.
Check for the Zilver 518 Biliary Stent 5mm x 20mm with catalog number ZIB5-125-5.0-20. This product is used for palliative treatment of biliary tree cancers.
Check the current instructions for use for the Zilver 518 Biliary Stent to ensure they match the corrected version.
The recall addresses a technical error in the instructions, not the stent itself. It is safe when using the updated instructions.
The recall does not require returning the stent; it only requires updating the instructions for use.
Look for the Zilver 518 Biliary Stent 5mm x 20mm with catalog number ZIB5-125-5.0-20.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0319-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0319-2019 from Cook Medical. 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.
