In a significant development, Philips has halted the distribution and sale of its Tack Endovascular System, a device used to repair damaged arteries. The decision comes following reports of 20 injuries and instances where the device required removal. The Food and Drug Administration (FDA) issued an urgent recall notice on Monday, categorizing it as Class I—the highest risk level—due to potential severe complications. Despite these issues, Philips confirmed that no serious harm or fatalities have been reported in association with the device.

Details of the Recall

In the autumn of 2020, Philips acquired Intact Vascular for $275 million, gaining ownership of the Tack Endovascular System. This metal implant was initially hailed as the first FDA-approved vascular device for below-the-knee treatments, designed to address arterial dissections following minimally invasive procedures to open blocked arteries. However, challenges emerged during its use, leading Philips to take decisive action.

The FDA highlighted several risks associated with the device, including partial or complete blockage of blood flow, tears in the artery lining, and perforation. Long-term concerns involve re-narrowing of treated vessels, bypass surgery, amputation, and even death. In response to these findings, Philips instructed customers via a January 10 letter to immediately inspect and quarantine any affected units. Over 2,900 devices were distributed across the U.S. and Europe, with the vast majority—nearly 2,700—distributed within the United States alone.

Philips has initiated a return and credit process for all impacted devices, ensuring that healthcare providers can swiftly address any lingering concerns. The company remains committed to patient safety and will continue to monitor and respond to any emerging issues.

From a journalist's perspective, this recall underscores the critical importance of continuous monitoring and evaluation of medical devices post-market. It highlights the need for robust quality control measures and transparent communication between manufacturers, regulatory bodies, and healthcare providers. Patients who may have received this treatment should consult their healthcare providers for further guidance, ensuring their safety and peace of mind.