Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0340-2019·Announced 2018-11-07

Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error

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.

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, but the source text identifies the issue as a documentation error (incorrect IFU) rather than a physical defect or reported injury, aligning with the 'Moderate' criteria for minor labeling/documentation errors.

Plain-English summary

Cook Medical Incorporated is recalling 9,834 units of the Zilver 635 Biliary Stent 12mm x 80mm (Catalog Number: ZIB6-80-12.0-80). The recall is being conducted because the instruction for use (IFU) contains incorrect details regarding the removal of the delivery system as part of the stent deployment process. 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 specific Global Product Number (GPN) for the affected lot is G36231.

Healthcare providers and facilities should stop using the affected stents and contact Cook Medical Incorporated for further instructions on the correction of the IFU. This recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 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: mis-labeling
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: G36231

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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.

See all 39 products in this recall →

Same manufacturer · Cook Medical Incorporated

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