Philips issues Class I recall for Tack endovascular system

Philips has recently announced that it will no longer sell its Tack endovascular system in the USA following a Class I recall issued by the US Food and Drug Administration (FDA).

A Class I recall is the FDA’s most serious classification, which denotes that the continued use of the affected product could result in severe injury or death.

The FDA’s decision follows reports that the Tack endovascular system—designed to treat arterial dissections—has posed challenges for users, sometimes necessitating additional interventions to retrieve or remove the implant. The self-expanding device is composed of nitinol, a nickel-titanium alloy.

The device is used following angioplasty, a procedure that widens narrowed or blocked arteries. While rare, tears in blood vessels can be a serious complication, and the Tack implant is designed to repair these by securing damaged tissue to the artery wall.

The FDA warned that continued use of the device could lead to significant health risks. Short-term complications include partial or complete blockage of blood flow, perforations in the artery’s inner lining, or full-thickness arterial tears. Long-term consequences may involve pain, tissue loss, re-narrowing of the vessel, and, in more severe cases, bypass surgery, amputation, or death.

Philips has reported 20 injuries linked to the Tack system but has not received any reports of fatalities.

The Tack system was initially approved by the FDA in April 2020. It was developed by Intact Vascular, a cardiovascular company acquired by Philips for US$275 million later that year.