Cook Medical recalls Zilver 518 Biliary Stent 5mm x 30mm (ZIB5-125-5.0-30) due to incorrect deployment instructions in the user manual. This correction prevents potential misuse during stent placement procedures.
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 518 Biliary Stents (5mm x 30mm) because the instructions for removing the delivery system during deployment were incorrect. This correction ensures safer use of the stent in medical procedures.
The recall addresses an error in the instructions for removing the delivery system when placing the stent. This could lead to improper deployment if followed incorrectly, though the hazard is corrected through updated instructions.
Healthcare professionals who use the Zilver 518 Biliary Stent during medical procedures are affected. Patients receiving this stent for biliary tree palliation are not directly at risk from the recall.
Check for the Zilver 518 Biliary Stent with catalog number ZIB5-125-5.0-30. The product is used for palliating malignant neoplasms in the biliary tree.
Check the manufacturer's website for corrected instructions on deploying the stent.
No, the recall addresses a correction to the deployment instructions for healthcare professionals, not a direct risk to patients.
Look for the Zilver 518 Biliary Stent with catalog number ZIB5-125-5.0-30.
No, the recall requires updating the instructions, not stopping use.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0320-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0320-2019 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.
