Cook Medical recalls Zilver 518 Biliary Stent 4mm x 30mm (Catalog ZIB5-125-4.0-30) due to incorrect deployment instructions in the user manual. This correction prevents potential errors 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 a specific biliary stent model because the instructions for removing the delivery system during deployment were incorrect. This fix ensures safer placement of the stent to avoid complications.
The incorrect instructions could lead to improper removal of the delivery system during stent deployment. This might cause the stent to be placed incorrectly, potentially causing complications for patients.
Patients who have received this specific biliary stent for cancer treatment are likely affected. Medical professionals using the stent during procedures may also be impacted.
Check for the Zilver 518 Biliary Stent 4mm x 30mm with catalog number ZIB5-125-4.0-30. This product is used for palliating cancer-related blockages in the bile ducts.
Check the current user manual for the stent to confirm the deployment instructions have been updated.
The recall addresses a correction to the deployment instructions, not an immediate safety risk. The stent itself is safe when used with the updated instructions.
The recall does not require returning the stent; it only requires updating the instructions for proper use.
Cook Medical provided the correction to the instructions, but medical professionals should consult their healthcare provider for specific guidance.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0315-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0315-2019 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.
