Cook Medical recalls Zilver 635 Biliary Stent 12mm x 40mm (ZIB6-125-12.0-40) due to incorrect deployment instructions in the user manual. This correction prevents potential complications 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 This could lead to improper stent placement if users follow outdated guidance.
The recall addresses an error in the instructions for removing the delivery system during stent deployment. If healthcare providers follow the incorrect instructions, it could lead to improper stent placement. However, the hazard is limited to the manual and does not involve immediate physical risks.
Healthcare professionals who use the Zilver 635 Biliary Stent 12mm x 40mm (catalog number ZIB6-125-12.0-40) for biliary procedures are affected. Patients receiving this stent are at low risk as the hazard is a procedural error in the manual, not a direct safety issue.
Check for the Zilver 635 Biliary Stent 12mm x 40mm with catalog number ZIB6-125-12.0-40. This product is used for palliating malignant neoplasms in the biliary tree.
Check the manufacturer's website for the corrected instructions to ensure proper deployment.
No, the hazard is a procedural error in the instructions, not a direct safety risk. The stent itself is safe when used with the corrected instructions.
No, the recall does not require stopping use. Healthcare providers should follow the updated instructions to avoid procedural errors.
Review the updated instructions from Cook Medical to ensure proper deployment. No action is needed beyond following the corrected guidance.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0325-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0325-2019 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.
