Cook Medical recalls Zilver Biliary 518 Stent 5mm x 60mm (Catalog ZIB5-125-5.0-60) due to incorrect deployment instructions in the user manual. This may affect safe use of the stent for biliary tree palliation.
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 a specific biliary stent model because the instructions for removing the delivery system during deployment are incorrect. This could lead to improper stent placement if users follow outdated instructions.
The user manual contains incorrect steps for removing the delivery system when placing the stent. This could cause improper stent placement if medical staff follow outdated instructions during procedures.
Patients who have received this specific biliary stent for cancer treatment. Medical professionals using the stent during procedures are most at risk of errors.
Check for the Zilver Biliary 518 Stent 5mm x 60mm with catalog number ZIB5-125-5.0-60. This stent is used for treating biliary tree cancers and was sold under the product name 'Zilver 518 and 635 Biliary Stents'.
Verify the stent model and catalog number to confirm if it matches the recalled item.
The recall is due to incorrect deployment instructions in the user manual, not the stent itself. Proper use with updated instructions should be safe.
No immediate action is required. The recall addresses outdated instructions, not a safety hazard in normal use.
Check the catalog number on the stent packaging: ZIB5-125-5.0-60. This specific model is used for biliary tree cancer 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-0351-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0351-2019 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.
