Cook Medical recalls Zilver 518 Biliary Stent 4mm x 80mm (Catalog ZIB5-125-4.0-80) due to incorrect deployment instructions in the user manual. This correction prevents potential misuse during stent placement 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 the Zilver 518 Biliary Stent 4mm x 80mm (Catalog ZIB5-125-4.0-80) because the instructions for removing the delivery system during stent deployment are incorrect. This correction is critical to ensure safe medical procedures and prevent potential complications during stent placement.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. If the instructions are followed incorrectly, it could lead to improper stent placement, which might cause complications such as blockages or infections. However, the risk is contained to procedural errors during medical use.
Healthcare professionals who use this stent for biliary procedures are likely affected. Patients receiving this stent as part of palliative treatment for biliary cancers are at risk if the deployment instructions are followed incorrectly.
Check for the Zilver 518 Biliary Stent 4mm x 80mm with Catalog Number ZIB5-125-4.0-80. This product is used for palliative treatment of biliary cancers and is intended for medical procedures by healthcare professionals.
Check the current instructions for use to ensure they match the corrected version provided by Cook Medical.
The stent itself is safe, but the instructions for deployment were incorrect. Cook Medical has corrected the instructions to ensure safe use during medical procedures.
Look for the Zilver 518 Biliary Stent 4mm x 80mm with Catalog Number ZIB5-125-4.0-80, which is used for palliative treatment of biliary cancers.
No, the recall does not require stopping use. The issue is with the instructions, not the stent itself. Healthcare professionals should follow the corrected instructions.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0318-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0318-2019 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.
