Cook Medical recalls Zilver 635 Biliary Stent 4mm x 80mm (ZIB6-80-4.0-80) 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 (4mm x 80mm, catalog ZIB6-80-4.0-80) because the instructions for removing the delivery system during stent deployment were incorrect. This correction helps prevent errors that could lead to improper stent placement.
The recall addresses a technical error in the instructions for removing the delivery system during stent deployment. This error could lead to improper stent placement if followed incorrectly, but the risk is low as it's a procedural correction rather than a physical hazard.
Patients who have received the Zilver 635 Biliary Stent (4mm x 80mm) for biliary tree palliation are likely affected. Medical professionals using this stent for malignant neoplasms are at risk of incorrect deployment.
Check for the Zilver 635 Biliary Stent (4mm x 80mm) with catalog number ZIB6-80-4.0-80. This product is used for palliating malignant neoplasms in the biliary tree.
Check the product's instruction for use manual for the corrected deployment procedure.
The recall addresses a correction to deployment instructions, not an immediate safety hazard. The risk is low as it's a procedural error that can be fixed with updated instructions.
Review the updated instructions for proper deployment. The recall does not require immediate removal or replacement.
Look for the Zilver 635 Biliary Stent (4mm x 80mm) with catalog number ZIB6-80-4.0-80, used for biliary tree palliation.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0345-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0345-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
