Tack Endovascular System

2025: Discontinuation of Sales

On March 3, 2025, the U.S. Food and Drug Administration (FDA) announced that Philips had completely discontinued sales of defective Tack Endovascular System devices for the treatment of blood vessels. The use of this defective product can trigger the death of the patient.

Philips calls the Tack Endovascular System the first-of-its-kind implant stent specifically designed to provide precise treatment for peripheral arterial dissections after balloon angioplasty. The device can be used in surgical procedures above or below the knee. The implant has an adaptive size, which allows the device to adapt to the anatomy of the patient, while maintaining a relatively constant radial force. Thus, one Tack implant can be used in vessels of different diameters.

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Фото: Philips

However, as stated in the FDA notice, the use of the Tack Endovascular System can provoke serious adverse health effects, including the risks of partial or complete blocking of blood flow (occlusion) and rupture in the inner lining of the artery through the entire wall. There are also long-term risks, such as pain, tissue damage, re-narrowing of an enlarged or stented vessel, the need for bypass surgery, amputation of a limb, and even death.

As of the beginning of March 2025, 20 cases of harm to the health of patients due to the use of the Tack Endovascular System were registered. The distribution and use of the following products ceases:

• Tack Endovascular System (4F,1.5 - 4.5mm), 150cm;
• Tack Endovascular System (6F, 3.5 - 6.0mm), 135cm;
• Tack Endovascular System (6F, 4.0 - 8.0mm), 135cm.^[1]

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