Zilver 518 Biliary Stent recall issued due to incorrect instruction for use details
The FDA is recalling the Zilver 518 Biliary Stent because its instruction for use details were incorrect, requiring updated deployment guidance.
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 involves a minor labeling error (incorrect IFU) with no reported illnesses or injuries, which aligns with the rubric's definition of minor labeling errors warranting a moderate severity rating.
Plain-English summary
The FDA is recalling the Zilver 518 Biliary Stent (catalog number ZIB5-125-4.0-80) manufactured by Cook Medical Incorporated. The recall concerns incorrect instruction for use details regarding the removal of the delivery system during stent deployment, which requires correction of the Instructions for Use (IFU). These stents are intended for palliation of malignant neoplasms in the biliary tree and are distributed nationwide across the United States and Puerto Rico. Affected consumers should follow the corrected deployment procedures outlined in the revised IFU.
The recalled product
- Product
- Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 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: G36047
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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