Cook Medical recalls Zilver 518 Biliary Stent 5mm x 80mm (ZIB5-80-5.0-80) 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 ZIB5-80-5.0-80) because the instructions for removing the delivery system during stent deployment are incorrect. This correction is needed to prevent potential complications during medical procedures.
The recall addresses an error in the instructions for removing the delivery system when deploying the stent. Incorrect removal could lead to improper stent placement, potentially causing complications during medical procedures.
Patients who have received this specific biliary stent for palliation of malignant tumors are affected. Medical professionals using the stent during procedures are at risk if they follow outdated instructions.
Check for the Zilver 518 Biliary Stent 5mm x 80mm with catalog number ZIB5-80-5.0-80. This stent is used for palliating malignant tumors in the biliary system.
Check the manufacturer's website for the corrected instructions for deploying the stent.
The recall addresses a specific error in the instructions, not the stent itself. When used with the corrected instructions, the stent is safe.
No, the recall does not require stopping use. The issue is with the instructions, not the stent's safety.
Visit Cook Medical's website to download the updated instructions for deploying the stent.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0323-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0323-2019 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.
