Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a documentation error (incorrect instructions) rather than a physical defect in the device itself, and no injuries or illnesses are reported in the source text.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 635 Biliary Stent 14mm x 40mm (Catalog Number: ZIB6-80-14.0-40). The recall is due to an error in the instruction for use (IFU) document. Specifically, the instructions provided for removing the delivery system during the deployment of the stent are incorrect. The IFU is being corrected to amend these details.
The affected product is intended for the palliation of malignant neoplasms in the biliary tree. The recall covers units distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico. The Global Product Number (GPN) for the affected lot is G36234.
Healthcare providers and facilities should stop using the affected product and contact Cook Medical Incorporated for further instructions on how to return or dispose of the units. Patients who have already received the stent should contact their healthcare provider if they have questions or concerns regarding the procedure.
The recalled product
- Product
- Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Biliary Stent
- Hazard
- Affected units
- 9,834
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GPN: G36234
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cook Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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