ProPort (vascular devices)

History

2025: Devices turned out to be defective - they damage tissues and form scars

On March 19, 2025, the U.S. Food and Drug Administration (FDA) announced that Smiths Medical is recalling popular vascular devices ProPort. Due to a manufacturing defect, these implantable products can damage tissues, which also leads to the formation of scarring.

ProPort's implantable plastic ports are part of a system that provides access to veins. Such devices are implanted under the skin and can be used for a long period of time. The port system is a small chamber with a silicone membrane connected to a venous catheter. To use the device, the port membrane is punctured with a special needle, to which ordinary droppers or infusion pumps can then be connected.

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Фото: Freepik

The installation of the port system is required for patients who will have long-term medical treatment, in particular chemotherapy against cancer. The venous port system facilitates the administration of drugs, reduces discomfort for patients and significantly reduces the likelihood of damage to blood vessels. The materials from which the port system is made are biologically inert, do not cause negative reactions from the body and do not interact with drugs.

In the case of Smiths Medical ProPort products, due to a defect, separation of the plastic port body and reservoir before, during or after implantation may occur. This can provoke serious adverse health effects, including complications due to delay or interruption of life-saving therapy, and damage to or scarring of the skin and tissues around the port due to contact with leaking intravenous drugs. There is a possibility of air embolism and death. As of March 2025, two cases of harm to the health of patients are known.^[1]

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