Cook Medical recalls Zilver 635 Biliary Stents due to incorrect deployment instructions in the user manual. This could lead to improper stent placement during medical procedures. Affected units have catalog number ZIB6-125-14.0-60.
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 60mm) because the instructions for removing the delivery system during stent deployment are incorrect. This could cause improper placement of the stent during medical procedures, potentially affecting patient safety.
The recall addresses a technical error in the instructions for removing the delivery system during stent deployment. This could lead to improper stent placement if healthcare providers follow outdated instructions. However, the risk is low as the issue is limited to documentation and not the physical product.
Healthcare professionals using the Zilver 635 Biliary Stent for medical procedures are most at risk. Patients receiving this stent as part of palliative treatment for biliary tree cancers are also affected.
Check for the catalog number ZIB6-125-14.0-60 on the stent packaging. The product is used for palliative treatment of biliary tree cancers and is intended for medical procedures.
Check for the corrected instructions for stent deployment in the product documentation.
The stent itself is safe, but the instructions for deployment need correction to ensure proper use.
Look for the catalog number ZIB6-125-14.0-60 on the stent packaging.
No, the recall is about updating the instructions, not removing the stent.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0330-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0330-2019 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.
