Cook Medical recalls Zilver 635 Biliary Stents (5mm x 60mm) due to incorrect deployment instructions in the user manual. Affected units may require correction to prevent improper 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 (5mm x 60mm) because the user manual has incorrect instructions for removing the delivery system during stent deployment. This could lead to improper placement if the stent is not installed correctly.
The user manual contains incorrect instructions for removing the delivery system during stent deployment. This could result in the stent being placed incorrectly, which might not function as intended for biliary tree palliation. However, the recall does not indicate a risk of serious injury or death.
Patients who have received the Zilver 635 Biliary Stent (5mm x 60mm) from Cook Medical are likely affected. Medical professionals using this stent for biliary tree palliation are at risk of improper placement if instructions are followed incorrectly.
Check for the Zilver 635 Biliary Stent (5mm x 60mm) with catalog number ZIB6-125-5.0-60. This product was used for palliation of malignant neoplasms in the biliary tree.
Check the user manual for the correct deployment instructions for removing the delivery system.
The recall addresses incorrect instructions in the user manual, but it does not indicate a risk of serious injury or death. The hazard level is low risk.
Look for the Zilver 635 Biliary Stent (5mm x 60mm) with catalog number ZIB6-125-5.0-60.
Review the user manual for the correct deployment instructions to ensure proper stent placement.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0335-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0335-2019 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.
