Pipeline Vantage (vascular devices)

History

2025: Risk of Death with Product Use

On March 18, 2025, the U.S. Food and Drug Administration (FDA) announced the recall of Pipeline Vantage vascular devices manufactured by Medtronic. The use of these products can provoke the death of patients.

Pipeline Vantage devices are designed for embolization. This is an X-ray endovascular procedure, the essence of which is selective occlusion (blockage) of blood vessels. Embolization is used, in particular, in oncology to worsen the blood supply to malignant formations. The procedure is also used to stop gastrointestinal bleeding and bleeding triggered by botched surgery or trauma. The advantages of the method include low invasiveness (the procedure does not require sutures and does not leave behind large postoperative scars), minimal risk of infectious complications, rapid recovery after intervention, preservation of the integrity and functional activity of organs and tissues. In addition, general anesthesia for embolization is rarely used or not used.

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Фото: Freepik

In the case of Pipeline Vantage products, the problem is associated with a flexible braided tubular element: there is a possibility that it will not be able to properly attach or remain attached to the wall of a blood vessel. This can lead to serious adverse health effects, including thrombosis, stroke, or death.

As of March 2025, 17 cases of harm to the health of patients in connection with the use of these products were registered. In addition, four deaths were recorded. Health care facilities need to stop using devices that are eligible for the recall program.^[1]

Notes