Cook Medical recalls Zilver 635 Biliary Stent 14mm x 40mm 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 stent placement and complications if the device is used without the updated instructions.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. This could result in improper placement if the device is used without the corrected instructions. However, the hazard does not involve immediate physical harm or failure in normal use.
Healthcare professionals who use the Zilver 635 Biliary Stent 14mm x 40mm (Catalog Number: ZIB6-125-14.0-40) for treating biliary tree cancers. Patients using this stent are not directly affected by the recall.
Check for the Zilver 635 Biliary Stent 14mm x 40mm with Catalog Number ZIB6-125-14.0-40. The product is used for palliating malignant neoplasms in the biliary tree.
Check the manufacturer's website for the corrected instructions for deployment of the Zilver 635 Biliary Stent.
No, this recall does not affect patients directly. The issue is with the instructions for healthcare professionals during stent deployment.
If you are a healthcare professional using this stent, review the updated instructions from Cook Medical. Patients are not affected by this recall.
Look for the Zilver 635 Biliary Stent 14mm x 40mm with Catalog Number ZIB6-125-14.0-40.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0329-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0329-2019 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.
