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Philips will no longer sell its Tack endovascular system in the US following a Class I recall by the US Food and Drug Administration (FDA).
Class I is the most serious designation for a recall issued by the FDA, indicating that continued use of the recalled products, without actions being taken, could cause serious injury or death.
Investor reaction to the recall was muted, with shares in the Dutch medtech giant opening relatively unchanged on the New York Stock Exchange compared to market close yesterday. Philips' stock also seemingly rebuffed wider losses seen across Wall Street after US President Trump announced the start of tariffs imposed on Mexico, Canada, and China.
The Class I designation for Philips comes after reports that its Tack endovascular system, used to treat tears in the inner lining of artery walls, causes challenges to customers during use. This includes additional interventions that have been required to retrieve or remove the implant. The self-expanding device is made of nitinol, a nickel-titanium alloy.
A Philips spokesperson told Medical Device Network: “Philips has become aware of challenges customers may have experienced with affected systems, and reports of instances where additional clinical intervention was required during device use.
“These issues may affect approximately 3,000 units, with all but 246 units in the US. The Tack endovascular system is no longer being distributed by Philips.”
The device is used after angioplasty, a procedure is used to widen narrowed or blocked arteries. Tears in blood vessels are a rare but serious complication of these, for which the Tack implant is utilised to attach damaged tissue to the inner lining of the blood vessel to repair dissection.
Following identification of issues, the FDA stated that continued use of the device can cause “serious adverse health consequences”. This includes short-term risks such as partial or completely blocked blood flow, holes or tears in the inner lining of the artery, and holes or tears that go through the entire artery wall. Long-term risks include pain, tissue loss, and re-narrowing of an already treated vessel. More serious long-term complications comprise bypass surgery, amputation, and death.
Philips has reported 20 injuries linked to issues with the Tack endovascular system, though no deaths have occurred.
The spokesperson confirmed: “At the time of this notification, Philips is not aware of the occurrence of serious injury/harm or death accompanying use of the Tack endovascular system.”
Philips sent a letter to customers of the device in January 2025 recommending, amongst other precautions, to immediately stop using affected Tack endovascular systems, and to return unused product to the company.