Cook Medical recalls Zilver 635 Biliary Stents due to incorrect deployment instructions in the user manual. This may affect safe use during medical 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 Zilver 635 Biliary Stents (12mm x 30mm) because the instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper placement if the user follows outdated instructions.
The recall addresses a technical error in the instructions for removing the delivery system during stent deployment. If the instructions are followed incorrectly, the stent might not be placed properly, potentially causing complications during medical procedures.
Healthcare professionals using the Zilver 635 Biliary Stent for medical procedures are likely affected. Patients receiving this stent as part of treatment may also be impacted.
Check for the Zilver 635 Biliary Stent with catalog number ZIB6-80-12.0-30. This product is used for palliating malignant neoplasms in the biliary tree.
Check for the corrected instructions for deployment of the stent in the product documentation.
The recall addresses a correction to the deployment instructions, not a safety issue with the stent itself. It is safe when using the updated instructions.
Look for the Zilver 635 Biliary Stent with catalog number ZIB6-80-12.0-30.
No, the recall does not require stopping use; it only requires 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-0337-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0337-2019 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.
