Cook Medical recalls Zilver 635 Biliary Stents due to incorrect removal instructions in the product manual. This could lead to improper deployment. Affected units have catalog number ZIB6-125-5.0-30.
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 30mm) because the product's instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper stent placement if users follow outdated instructions.
The product's instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper stent placement if users follow outdated instructions. However, the hazard is corrected through a revised instruction manual without immediate action required.
Patients who have received the Zilver 635 Biliary Stent (5mm x 30mm) for biliary tree palliation are likely affected. Medical professionals using the stent for malignant neoplasms are at higher risk due to the critical nature of the procedure.
Check for the catalog number ZIB6-125-5.0-30 on the stent packaging or label. The product is intended for palliation of malignant neoplasms in the biliary tree.
Check the manufacturer's website for the corrected instructions for use to ensure proper deployment.
The recall is due to incorrect instructions in the product manual, not the stent itself. Using the stent correctly with updated instructions is safe.
No immediate action is required. The hazard is corrected through updated instructions, so users can continue with the product if they follow the revised instructions.
Review the updated instructions on Cook Medical's website to ensure proper deployment. No return or replacement is needed.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0333-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0333-2019 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.
