Cook Medical recalls Zilver 635 Biliary Stent 14mm x 80mm 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 a specific type of biliary stent because the instructions for removing the delivery system during deployment are incorrect. This could lead to improper stent placement and potential complications if the procedure is done without the updated instructions.
The incorrect deployment instructions could lead to improper removal of the delivery system during stent placement. This might cause the stent to be placed incorrectly, potentially causing complications such as blockages or infections in the biliary tract.
Healthcare professionals who use the Zilver 635 Biliary Stent 14mm x 80mm (Catalog Number: ZIB6-80-14.0-80) for biliary procedures are most at risk. Patients receiving this stent as part of palliative treatment for malignant tumors may also be affected.
Check for the Zilver 635 Biliary Stent 14mm x 80mm with Catalog Number ZIB6-80-14.0-80. This product is used for palliative treatment of malignant tumors in the biliary system.
Check the manufacturer's website for the corrected instructions for deployment of the stent.
The recall is due to incorrect deployment instructions, not a safety issue with the stent itself. Using the stent with the updated instructions is safe.
Look for the Zilver 635 Biliary Stent 14mm x 80mm with Catalog Number ZIB6-80-14.0-80.
Review the updated deployment instructions from Cook Medical's website. No immediate action is required beyond following the corrected instructions.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0344-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0344-2019 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.
