Cook Medical recalls Zilver 635 Biliary Stent 5mm x 30mm (ZIB6-80-5.0-30) due to incorrect removal instructions in the product manual. This may lead to improper stent deployment.
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 5mm x 30mm (catalog number ZIB6-80-5.0-30) because the instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper stent placement if the device is used without following the updated instructions.
The recall addresses an error in the instructions for removing the delivery system when deploying the stent. If the incorrect instructions are followed, the stent may not be placed properly, potentially causing complications during medical procedures.
Patients who have received the Zilver 635 Biliary Stent 5mm x 30mm (catalog number ZIB6-80-5.0-30) for biliary tree palliation are affected. Medical professionals using this stent during procedures are at risk of improper deployment.
Check for the Zilver 635 Biliary Stent 5mm x 30mm with catalog number ZIB6-80-5.0-30. This product is used for palliating malignant neoplasms in the biliary tree.
Check the manufacturer's website for the corrected instructions for stent deployment.
The stent is safe to use once the updated instructions are followed. The recall addresses a correction to the instructions, not a safety issue with the stent itself.
No, the recall does not require stopping use. The issue is with the instructions, not the stent's safety.
Review the updated instructions from Cook Medical to ensure proper deployment. No action is needed beyond following the corrected 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-0347-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0347-2019 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.
