Cook Medical recalls Zilver 518 Biliary Stent 4mm x 40mm (ZIB5-125-4.0-40) due to incorrect deployment instructions in the user manual. This correction prevents potential errors 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 fix prevents potential errors that could lead to improper stent placement.
The user manual contains incorrect steps for removing the delivery system during stent deployment. This could lead to improper placement of the stent, which might cause complications in patients with biliary cancer.
Patients who have received this specific biliary stent for cancer treatment are likely affected. Medical professionals using the stent during procedures are at higher risk due to the incorrect instructions.
Check for the Zilver 518 Biliary Stent 4mm x 40mm with catalog number ZIB5-125-4.0-40. This stent is used for palliating malignant tumors in the biliary system.
Check the user manual for the correct deployment steps to ensure safe stent placement.
The recall is due to incorrect instructions in the user manual, not the stent itself. Using it correctly should be safe.
The recall does not require returning the stent; it only requires updating the instructions.
Contact Cook Medical directly for guidance on the updated 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-0316-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0316-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
