Cook Medical recalls Zilver 518 Biliary Stent 5mm x 80mm (Catalog ZIB5-125-5.0-80) due to incorrect deployment instructions in the user manual. This correction prevents potential complications during stent placement.
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 5mm x 80mm (Catalog Number ZIB5-125-5.0-80) because the instructions for removing the delivery system during stent deployment are incorrect. This correction helps prevent potential complications during medical procedures.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. This could lead to improper placement if healthcare providers follow outdated instructions. The correction ensures safer deployment procedures.
Healthcare professionals who use this stent for biliary procedures are 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 5mm x 80mm with Catalog Number ZIB5-125-5.0-80. This product is used for palliative treatment of biliary cancers.
Check the manufacturer's website for the corrected instructions for deployment of the stent.
Yes, the Zilver 518 Biliary Stent is intended for palliation of malignant neoplasms in the biliary tree.
The recall is due to incorrect instructions for removing the delivery system during stent deployment, which the manufacturer is correcting.
No, the recall does not require stopping use; it involves updating the instructions for safer deployment.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0322-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0322-2019 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.
