Cook Medical recalls Zilver 635 Biliary Stent 5mm x 20mm (ZIB6-125-5.0-20) due to incorrect deployment instructions in the user manual. This correction prevents potential errors 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 Zilver 635 Biliary Stents (5mm x 20mm, catalog ZIB6-125-5.0-20) because the instructions for removing the delivery system during deployment are incorrect. This correction ensures safe stent placement in patients with biliary tree cancer.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. This could lead to improper placement if followed incorrectly, but the hazard is corrected through updated instructions without immediate risk to users.
Patients who have received the Zilver 635 Biliary Stent (5mm x 20mm, catalog ZIB6-125-5.0-20) for biliary tree cancer treatment are affected. Medical professionals using this stent during procedures are at risk of incorrect deployment.
Check for the Zilver 635 Biliary Stent (5mm x 20mm) with catalog number ZIB6-125-5.0-20. This product is used for palliating malignant neoplasms in the biliary tree.
Check the corrected instructions for deployment to ensure proper removal of the delivery system.
The recall addresses a correction to deployment instructions, not an immediate safety hazard. The hazard is corrected through updated instructions.
Review the corrected instructions for deployment to ensure proper removal of the delivery system.
No serious injury risk is stated in the recall. The hazard is a procedural error that is corrected through updated 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-0332-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0332-2019 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.
