Cook Medical recalls Zilver 635 Biliary Stents (12mm x 40mm) due to incorrect deployment instructions in the user manual. Affected patients should contact the company for guidance.
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 40mm) because the instructions for removing the delivery system during stent deployment are incorrect. This could lead to improper stent placement if users follow outdated instructions.
The recall addresses a technical error in the user manual regarding how to remove the delivery system during stent deployment. Incorrect instructions could lead to improper stent placement, but the risk is low as the stent is used in a specific medical context.
Patients who have received the Zilver 635 Biliary Stent (12mm x 40mm) for biliary tree palliation are affected. Medical professionals using this stent for malignant neoplasms are at risk if they follow outdated instructions.
Check for the Zilver 635 Biliary Stent (12mm x 40mm) with catalog number ZIB6-80-12.0-40. The product is used for palliating malignant neoplasms in the biliary tree.
Reach out to Cook Medical for guidance on the correct deployment instructions for the Zilver 635 Biliary Stent.
The recall addresses a technical error in the instructions, not the stent itself. The stent is safe when used with the corrected instructions.
Look for the Zilver 635 Biliary Stent (12mm x 40mm) with catalog number ZIB6-80-12.0-40.
The recall does not require returning the stent; users should contact Cook Medical for updated 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-0338-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0338-2019 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.
