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 (5mm x 60mm) 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 user manual contains incorrect instructions for removing the delivery system when placing the stent. This could result in improper stent placement during medical procedures, potentially causing complications.
Patients receiving biliary stent procedures from Cook Medical. Medical professionals using these stents are most at risk of errors during deployment.
Check for the Zilver 635 Biliary Stent (5mm x 60mm) with catalog number ZIB6-80-5.0-60. These stents are used for palliating malignant tumors in the biliary system.
Check the manufacturer's website for the corrected instructions to ensure safe deployment.
This recall applies to Zilver 635 Biliary Stents (5mm x 60mm) with catalog number ZIB6-80-5.0-60. If you have this specific model, you should review the updated instructions.
The recall does not require immediate action. Review the corrected instructions from Cook Medical to ensure safe deployment.
The recall addresses incorrect deployment instructions, which could lead to improper placement. However, the hazard is not described as causing serious injury in normal use.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0349-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0349-2019 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.
