Cook Medical recalls Zilver 635 Biliary Stents 12mm x 60mm (Catalog ZIB6-125-12.0-60) due to incorrect deployment instructions in the user manual. Affected patients should contact the manufacturer for guidance.
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 12mm x 60mm (Catalog ZIB6-125-12.0-60) because the instructions for removing the delivery system during stent deployment are incorrect. This correction is needed to ensure safe use of the medical device.
The user manual contains incorrect instructions for removing the delivery system during stent deployment. This could lead to improper placement or complications if the stent is not deployed correctly. However, the hazard is corrected through a manual update without immediate action needed from users.
Patients who have received the Zilver 635 Biliary Stent 12mm x 60mm (Catalog ZIB6-125-12.0-60) for biliary tree palliation. Medical professionals using this stent in procedures are most at risk of errors during deployment.
Check for the Zilver 635 Biliary Stent 12mm x 60mm with Catalog Number ZIB6-125-12.0-60. This product is used for biliary tree palliation in patients with malignant neoplasms.
Reach out to Cook Medical Incorporated for guidance on the corrected instructions and any necessary steps.
The recall is due to incorrect instructions in the user manual, not the stent itself. Corrected instructions ensure safe deployment.
No immediate action is required. The hazard is addressed by updating the instructions, so users can continue with the stent if following the corrected manual.
Contact Cook Medical Incorporated directly for specific guidance on the corrected instructions and any necessary steps.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0326-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0326-2019 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.
