Agency classClass IIOur severity:Severe FDA (Devices)·Z-2623-2016·Announced 2016-08-31

Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture

Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a Class II medical device with reported complications including embolization and occlusion of blood flow, which constitutes a significant injury risk under the rubric.

Plain-English summary

Cook Inc. is recalling 3,425 units of the White Lumax Guiding Coaxial Catheter, a percutaneous catheter intended for the delivery of angioplasty balloons and other interventional devices. The recall covers all lots, specifically catalog/product number LMGRF-7.0C-80-MPA-PULM G11164. The devices were distributed nationwide in the United States and internationally to numerous countries.

The recall is being conducted due to an increase in reports of polymer degradation at the catheter tip, which can result in tip fracture and/or separation. This degradation can lead to a loss of device function or the separation of a device segment, potentially requiring additional medical intervention.

Complications from separated segments may include device fragments remaining in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occlusion of blood flow to end organs. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.

The recalled product

Product: White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
Manufacturer: Cook Inc.
Category: Medical Device — Interventional Catheter
Hazard: device-fracture
embolization
vascular-occlusion
Affected units: 3,425

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 (2)

All Lots. Catalog/product number
Global/order number LMGRF-7.0C-80-MPA-PULM G11164

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Cook Inc. 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 14 products in this recall →

Same manufacturer · Cook Inc.

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Same hazard · device fracture