Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 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, and the source text identifies the issue as an incorrect instruction for use detail rather than a physical defect or reported injury, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 518 Biliary Stent (5mm x 80mm, Catalog Number ZIB5-125-5.0-80). The recall was initiated because the instruction for use (IFU) contains incorrect details regarding the removal of the delivery system as part of the stent deployment process. The manufacturer is correcting the IFU 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 General Product Number (GPN) for the affected items is G36048.
Healthcare providers and patients should contact Cook Medical Incorporated for further information regarding the correction of the instructions for use.
The recalled product
- Product
- Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 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: G36048
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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