Cook Medical recalls Zilver 635 Biliary Stents (5mm x 20mm) due to incorrect deployment instructions in the user manual. This correction prevents potential complications during stent placement.
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 (5mm x 20mm) because the instructions for removing the delivery system during stent deployment were incorrect. This could lead to improper placement and complications if used without the updated instructions.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. Incorrect removal could lead to improper stent placement, potentially causing complications such as blockages or infections. However, the hazard is corrected through a revised instruction manual.
Patients who have received the Zilver 635 Biliary Stent (5mm x 20mm) from Cook Medical are likely affected. Medical professionals using this stent for biliary tree palliation may be at higher risk if following outdated instructions.
Check for the Zilver 635 Biliary Stent with a catalog number ZIB6-80-5.0-20. This product is used for biliary tree palliation in patients with malignant neoplasms.
Check the manufacturer's website or contact Cook Medical for the corrected instructions to ensure safe deployment.
The recall addresses a correction to deployment instructions, not an immediate safety hazard. Using the stent with outdated instructions could lead to improper placement, but the risk is low with the updated instructions.
No, but you should follow the corrected instructions to ensure safe deployment. The recall does not require immediate removal.
Look for the catalog number ZIB6-80-5.0-20 on the stent packaging or label. This product is used for biliary tree palliation in patients with malignant neoplasms.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0346-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0346-2019 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.
