Cook Medical recalls Zilver 518 Biliary Stent 4mm x 60mm (ZIB5-125-4.0-60) 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 4mm x 60mm (catalog number ZIB5-125-4.0-60) because the instructions for removing the delivery system during stent deployment are incorrect. This correction is needed to ensure safe and proper stent placement procedures.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. This could lead to improper stent placement if followed incorrectly, potentially causing complications during medical procedures.
Patients who have received this specific biliary stent for palliation of malignant tumors 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 60mm with catalog number ZIB5-125-4.0-60. This product is used for palliation of malignant neoplasms in the biliary tree.
Check the current instructions for use to ensure they match the corrected version provided by Cook Medical.
The recall is due to incorrect instructions for removing the delivery system during stent deployment, which could lead to improper placement.
The stent is safe when used with the corrected instructions, but the current instructions are incorrect and need to be updated.
Review the instructions for use to ensure they follow the corrected version; no action is needed beyond verifying the 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-0317-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0317-2019 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.
