Cook Medical recalls Zilver 635 Biliary Stent 4mm x 80mm (Catalog ZIB6-125-4.0-80) 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 the Zilver 635 Biliary Stent 4mm x 80mm (Catalog ZIB6-125-4.0-80) because the instructions for removing the delivery system during stent deployment were incorrect. This fix ensures safer placement of the stent to avoid complications.
The incorrect instructions could lead to improper removal of the delivery system during stent deployment. This might cause complications such as improper stent placement or tissue damage, though the risk is not severe in normal use.
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 product name 'Zilver 635 Biliary Stent 4mm x 80mm' and catalog number ZIB6-125-4.0-80. This stent is used for palliating malignant tumors in the biliary system.
Check the current user manual for the Zilver 635 Biliary Stent to ensure it follows the corrected instructions.
The recall addresses incorrect deployment instructions, not inherent danger. The stent is safe when used with the corrected instructions.
The official notice does not specify a return requirement; only the instructions are being corrected.
Review the updated instructions for proper deployment. No action is needed beyond following the corrected manual.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0331-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0331-2019 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.
