Cook Medical recalls Zilver 635 Biliary Stent 12mm x 30mm (Catalog ZIB6-125-12.0-30) due to incorrect deployment instructions in the user manual. Affected users should contact Cook for clarification.
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 stent deployment are incorrect. This could lead to improper use if the user follows outdated instructions.
The recall addresses an error in the user manual's instructions for removing the delivery system during stent deployment. This could potentially lead to improper stent placement if the instructions are followed incorrectly. However, the hazard does not involve immediate physical harm or device failure.
Healthcare professionals using the Zilver 635 Biliary Stent 12mm x 30mm (Catalog ZIB6-125-12.0-30) for biliary tree procedures are affected. Patients receiving this stent are not at risk from the recall.
Check for the Zilver 635 Biliary Stent 12mm x 30mm with Catalog Number ZIB6-125-12.0-30. The product is used for biliary tree procedures in palliative care for malignant neoplasms.
Reach out to Cook Medical Incorporated for clarification on the correct deployment instructions.
The recall addresses an error in the user manual's instructions for deployment, but it does not pose an immediate risk to patients or users.
No, the recall does not require stopping use; it only requires updating the instructions for proper deployment.
Check for the Zilver 635 Biliary Stent 12mm x 30mm with Catalog Number ZIB6-125-12.0-30.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0324-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0324-2019 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.
