Cook Medical recalls Zilver 635 Biliary Stent 14mm x 30mm (ZIB6-80-14.0-30) 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 Zilver 635 Biliary Stents (14mm x 30mm) because the instructions for removing the delivery system during deployment are incorrect. This fix ensures safe placement of the stent to avoid complications.
The incorrect instructions could lead to improper removal of the delivery system during stent deployment. This might cause complications such as improper stent placement or tissue damage.
Patients using the Zilver 635 Biliary Stent for biliary tree palliation may be affected. Healthcare providers who have this stent in their inventory are most at risk.
Check for the Zilver 635 Biliary Stent with catalog number ZIB6-80-14.0-30. This product is used for biliary tree palliation in patients with malignant neoplasms.
Check the current instructions for use to ensure they match the corrected version provided by Cook Medical.
The recall applies to Zilver 635 Biliary Stents with catalog number ZIB6-80-14.0-30. If you have this specific model, you should review the updated instructions.
Cook Medical has corrected the instructions for use. There is no need to discard or return the stent; simply review the updated instructions.
The recall addresses a correction to the instructions, not a direct safety hazard. The risk is low as the issue is related to procedural instructions rather than physical harm.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0341-2019 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0341-2019 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.
