Cook Medical recalls Zilver 518 Biliary Stent 5mm x 40mm (Catalog ZIB5-125-5.0-40) 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 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 This could lead to improper stent placement if users follow outdated instructions.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. Incorrect removal could lead to improper stent placement, but the hazard is corrected through updated instructions without immediate risk to users.
Patients who have received the Zilver 518 Biliary Stent 5mm x 40mm (Catalog Number ZIB5-125-5.0-40) for biliary tree palliation are affected. Medical professionals using this stent during procedures are at risk if they follow outdated instructions.
Check for the Zilver 518 Biliary Stent 5mm x 40mm with Catalog Number ZIB5-125-5.0-40. This stent is used for biliary tree palliation in patients with malignant neoplasms.
Check the manufacturer's website for corrected instructions on stent deployment to ensure proper use.
No, the recall addresses a correction to deployment instructions, not an inherent risk of the stent itself.
The official recall does not require discarding the stent; users should follow updated instructions for safe deployment.
Look for the Catalog Number ZIB5-125-5.0-40 on the stent packaging or documentation.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0321-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0321-2019 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.
