Cook Medical recalls Zilver 635 Biliary Stents due to incorrect deployment instructions in the user manual. This may affect safe use during medical procedures. Affected units have catalog number ZIB6-125-5.0-40.
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 Zilver 635 Biliary Stents (5mm x 40mm) because the instructions for removing the delivery system during deployment are incorrect. This could lead to improper stent placement during medical procedures if the instructions are followed as written.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. If the instructions are followed incorrectly, it could lead to improper stent placement, which might cause complications during medical procedures.
Medical professionals using the Zilver 635 Biliary Stent for palliation of malignant tumors are most at risk. Patients receiving this stent as part of their treatment may also be affected.
Check for the catalog number ZIB6-125-5.0-40 on the stent packaging or label. The 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 for medical professionals using the stent during procedures. Patients receiving the stent as part of treatment are not directly affected by this recall.
The recall states that the instructions for removing the delivery system during deployment are incorrect and will be corrected. The updated instructions will be provided by Cook Medical.
Look for the catalog number ZIB6-125-5.0-40 on the stent packaging or label. The product 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-0334-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0334-2019 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.
