Cook Medical recalls Zilver 635 Biliary Stents due to incorrect deployment instructions in the user manual. This could lead to improper stent removal. Affected units have catalog number ZIB6-125-14.0-80.
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 80mm) because the instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper stent removal if the user follows the outdated instructions.
The recall addresses a technical error in the instructions for removing the delivery system during stent deployment. This could lead to improper stent removal if the outdated instructions are followed. However, the hazard does not involve immediate physical harm or injury.
Healthcare professionals who use these stents for biliary tree palliation are most at risk. Patients receiving the stents are not directly affected by the recall.
Check for the product name 'Zilver 635 Biliary Stent 14mm x 80mm' with catalog number ZIB6-125-14.0-80. The stents are used for biliary tree palliation in patients with malignant neoplasms.
Check the current instructions for use to ensure they match the corrected version provided by Cook Medical.
Cook Medical is recalling the Zilver 635 Biliary Stent due to incorrect deployment instructions in the user manual that could lead to improper stent removal.
No, the recall does not require stopping use. The hazard is a technical error in instructions, not a physical defect in the stent itself.
Look for the product name 'Zilver 635 Biliary Stent 14mm x 80mm' with catalog number ZIB6-125-14.0-80.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0352-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0352-2019 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.
