Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 adverse 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 12mm x 80mm (Catalog Number: ZIB6-125-12.0-80). The recall was initiated because the instruction for use (IFU) contains incorrect details concerning the removal of the delivery system during the deployment of the stent. The IFU is being corrected to amend these instructions.
The affected stents are 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 product is G36241.
Healthcare providers and facilities should stop using the affected stents and contact Cook Medical Incorporated for further instructions on the recall and replacement of the corrected instructions.
The recalled product
- Product
- Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 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: G36241
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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