Cook Medical recalls Zilver 518 Biliary Stent 4mm x 20mm (ZIB5-125-4.0-20) 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 the Zilver 518 Biliary Stent 4mm x 20mm (catalog number ZIB5-125-4.0-20) because the instructions for removing the delivery system during stent deployment are incorrect. This correction helps prevent errors that could lead to improper stent placement.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. This could lead to improper placement if followed incorrectly, potentially causing complications in the biliary tree.
Patients who have received the Zilver 518 Biliary Stent 4mm x 20mm (catalog number ZIB5-125-4.0-20) for biliary tree palliation are affected. Medical professionals using this stent during procedures are at risk of errors.
Check for the Zilver 518 Biliary Stent 4mm x 20mm with catalog number ZIB5-125-4.0-20. This stent is used for palliating malignant neoplasms in the biliary tree.
Check the current instructions for use to ensure they match the corrected version provided by Cook Medical.
The stent is safe when used with the corrected instructions for deployment. The recall addresses a specific error in the instructions, not the stent itself.
Review the updated instructions for use to ensure proper deployment. The recall does not require immediate removal or replacement.
The recall addresses a potential for improper placement due to incorrect instructions, but the stent itself is not hazardous. Serious injury is not expected with proper use.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0314-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0314-2019 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.
