Cook Medical recalls Zilver 635 Biliary Stent 5mm x 80mm (Catalog ZIB6-125-5.0-80) 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 its Zilver 635 Biliary Stent 5mm x 80mm (Catalog ZIB6-125-5.0-80) 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 incorrect instructions for removing the delivery system during stent deployment could lead to improper placement. This might cause complications such as incomplete stent deployment or tissue damage during the procedure.
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 potential procedural errors.
Check for the Zilver 635 Biliary Stent 5mm x 80mm with Catalog Number ZIB6-125-5.0-80. This product is used for palliation of malignant neoplasms in the biliary tree.
Check the current instructions for use to confirm the corrected deployment procedure for the Zilver 635 Biliary Stent.
The recall is for the product itself, not patients who have already received the stent. However, medical professionals should review the updated instructions for safe deployment.
The manufacturer has corrected the instructions for removing the delivery system during stent deployment to ensure safe placement.
Look for the Zilver 635 Biliary Stent 5mm x 80mm with Catalog Number ZIB6-125-5.0-80, which is used for palliation of malignant neoplasms in the biliary tree.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0336-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0336-2019 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.
