Cook Medical recalls Zilver 635 Biliary Stent 12mm x 80mm (Catalog ZIB6-125-12.0-80) due to incorrect deployment instructions in the user manual. This correction prevents potential errors 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 a specific biliary stent model because the instructions for removing the delivery system during deployment are incorrect. This correction is needed to ensure safe and proper stent placement procedures.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. This could lead to improper placement if followed incorrectly, though the hazard is not described as causing serious injury in normal use.
Patients who have received the Zilver 635 Biliary Stent 12mm x 80mm (Catalog ZIB6-125-12.0-80) for biliary tree palliation are affected. Healthcare providers using this stent for medical procedures are at risk of incorrect deployment.
Check for the Zilver 635 Biliary Stent 12mm x 80mm with catalog number ZIB6-125-12.0-80. This stent is used for palliating malignant neoplasms in the biliary tree.
Check the current instructions for use to confirm the corrected deployment procedure is followed.
The recall addresses an incorrect instruction in the user manual, not a safety issue with the stent itself when used correctly.
The recall does not require returning the stent; it only requires updating the instructions for use.
The catalog number is ZIB6-125-12.0-80.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0327-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0327-2019 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.
