Beacon Tip 5.0 Fr (angiographic catheters)

History

2025: Recall due to marriage

On June 25, 2025, the U.S. Food and Drug Administration (FDA) announced the recall of Beacon Tip 5.0 Fr angiographic catheters manufactured by Cook Medical. The use of these devices can cause serious harm to the health of patients and even provoke death.

Beacon Tip 5.0 Fr catheters are used in angiography: this is a contrast X-ray examination of blood vessels, which allows you to obtain detailed images of the arteries, veins, capillaries and blood flow inside them. During the procedure, the doctor makes a small puncture and injects a contrast agent through the catheter. A series of X-rays are then performed. At the end of the study, the catheter is removed from the body. Angiography allows you to detect damage and malformations of blood vessels - aneurysms, constrictions, impaired patency, as well as damage and malformations of various organs. Depending on the field of angiography, it is possible to detect various pathological processes, including ischemic stroke, hemorrhagic stroke, acute circulatory disorders in tissues, thrombophlebitis, vascular tumors, etc.

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Фото: Cook Medical

It has been found that defective Beacon Tip 5.0 Fr catheters may exhibit tip detachment. The use of such products can provoke sepsis, perforation of the vessel, thrombosis, embolism, cardiac arrhythmia and death.

As of the end of June 2025, three cases of significant harm to the health of patients due to the use of defective catheters are known. No fatal episodes were recorded. The FDA notice says healthcare facilities that purchased Beacon Tip 5.0 Fr products should stop using them immediately.^[1]

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