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 80mm) because the instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper placement or complications during medical procedures.
The recall addresses a technical error in the instructions for removing the delivery system during stent deployment. This could potentially lead to improper stent placement if followed incorrectly, but the hazard is not life-threatening in normal use.
Healthcare professionals who use these stents for biliary procedures are most at risk. Patients receiving the stents are not directly affected by this recall.
Check for the Zilver 635 Biliary Stent (12mm x 80mm) with catalog number ZIB6-80-12.0-80. The product is used for palliating malignant neoplasms in the biliary tree.
Check the current instructions for use for the Zilver 635 Biliary Stent to ensure they align with the corrected version.
No, this recall addresses a technical error in the instructions for healthcare professionals, not a direct risk to patients.
Look for the Zilver 635 Biliary Stent (12mm x 80mm) with catalog number ZIB6-80-12.0-80.
Review the updated instructions for use as the recall does not require immediate action beyond checking the current 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-0340-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0340-2019 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.
