Cook Medical recalls Zilver 635 Biliary Stent 12mm x 60mm (Catalog ZIB6-80-12.0-60) 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 (12mm x 60mm) because the instructions for removing the delivery system during deployment are incorrect. This could lead to improper stent placement if the user follows outdated instructions.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. Incorrect procedures could lead to improper stent placement, but the hazard is not immediate or life-threatening under normal use conditions.
Healthcare professionals who use the Zilver 635 Biliary Stent 12mm x 60mm (Catalog ZIB6-80-12.0-60) for biliary tree procedures are affected. Patients receiving this stent are at low risk as the issue relates to instructions, not direct harm.
Check for the Zilver 635 Biliary Stent 12mm x 60mm with Catalog Number ZIB6-80-12.0-60. This product is used for biliary tree procedures in palliative care for malignant neoplasms.
Check the manufacturer's website for corrected instructions to ensure proper deployment of the stent.
No, the recall addresses a correction to the instructions for deployment, not an immediate safety hazard. The risk is low and related to procedural accuracy.
No, the recall does not require stopping use. Healthcare providers should follow the updated instructions to ensure proper deployment.
The recalled product is the Zilver 635 Biliary Stent 12mm x 60mm with Catalog Number ZIB6-80-12.0-60, used for biliary tree procedures in palliative care.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0339-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0339-2019 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.
