Cook Medical recalls Zilver 635 Biliary Stent 14mm x 40mm (ZIB6-80-14.0-40) due to incorrect deployment instructions in the user manual. This correction prevents potential complications 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 (14mm x 40mm) because the instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper placement and complications if used without the updated instructions.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. Incorrect removal could lead to improper stent placement, potentially causing complications such as blockages or infections. The correction aims to ensure safe and effective use of the stent.
Healthcare professionals who use the Zilver 635 Biliary Stent 14mm x 40mm (Catalog Number: ZIB6-80-14.0-40) for biliary procedures are affected. Patients receiving this stent are at risk if the deployment instructions are followed incorrectly.
Check for the Zilver 635 Biliary Stent 14mm x 40mm with Catalog Number ZIB6-80-14.0-40. This product is used for palliating malignant neoplasms in the biliary tree.
Check the manufacturer's website for the corrected instructions to ensure safe deployment of the stent.
The recall is due to incorrect instructions for removing the delivery system during stent deployment, which could lead to improper placement.
The recall addresses a procedural error in instructions, not a direct risk of injury. The corrected instructions aim to prevent complications.
Look for the Zilver 635 Biliary Stent 14mm x 40mm with Catalog Number ZIB6-80-14.0-40.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0342-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0342-2019 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.
