Cook Medical recalls Zilver 635 Biliary Stents due to incorrect deployment instructions in the user manual. This may lead to improper stent removal. Affected units have catalog number ZIB6-80-14.0-60.
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 (14mm x 60mm) because the instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper stent removal if the device is used without following the corrected instructions.
The user manual contains incorrect details about removing the delivery system during stent deployment. This could result in improper stent placement or removal if healthcare providers follow the outdated instructions without the updated guidance.
Healthcare professionals who use the Zilver 635 Biliary Stent for biliary tree palliation are likely affected. Patients receiving this stent treatment may be at risk if the deployment instructions are followed incorrectly.
Check for the catalog number ZIB6-80-14.0-60 on the product. The Zilver 635 Biliary Stent is used for biliary tree palliation in patients with malignant neoplasms.
Check the manufacturer's website for the corrected instructions for deploying the Zilver 635 Biliary Stent.
The stent is safe to use with the updated instructions. The recall addresses a correction in the deployment instructions, not a safety issue with the stent itself.
Look for the catalog number ZIB6-80-14.0-60 on the product. The Zilver 635 Biliary Stent is used for biliary tree palliation in patients with malignant neoplasms.
No, the recall does not require stopping use. The issue is with the instructions, not the stent's safety. Updated instructions are available from the manufacturer.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0343-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0343-2019 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.
