Cook Medical recalls Zilver 635 Biliary Stents due to incorrect deployment instructions in the user manual. This correction prevents potential complications 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 635 Biliary Stents (14mm x 30mm) because the instructions for removing the delivery system during deployment are incorrect. This correction is needed to ensure safe and proper stent placement in medical procedures.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. This could lead to improper placement if followed incorrectly, but the hazard is corrected through updated instructions without immediate risk to users.
Healthcare professionals who use these stents for biliary tree palliation in cancer treatment are most at risk. Patients receiving these stents are not directly affected by this recall.
Check for the Zilver 635 Biliary Stent (14mm x 30mm) with catalog number ZIB6-125-14.0-30. These stents are used for palliating malignant neoplasms in the biliary tree.
Check the manufacturer's website for corrected instructions on deploying the stent.
No, this recall is for healthcare professionals using the stent during procedures. Patients are not affected by this correction.
Look for the Zilver 635 Biliary Stent (14mm x 30mm) with catalog number ZIB6-125-14.0-30.
No, the recall only requires updated instructions. Healthcare professionals should follow the corrected procedure without 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-0328-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0328-2019 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.
