Philips Recalls Tack Endovascular System After 20 Reported Injuries

Philips has pulled its Tack Endovascular System from the market following reports of 20 injuries requiring additional interventions for implant removal. The U.S. Food and Drug Administration (FDA) classified the recall as Class I, the highest-risk category, and urged healthcare providers to stop using the device immediately. While no deaths have been reported, the implant was found to pose risks such as arterial blockages, tears, and potential long-term complications, including bypass surgery and amputation.

Philips acquired the Tack System in 2020 through its $275 million purchase of Intact Vascular. Originally marketed as the first FDA-approved vascular implant for below-the-knee treatment, the device is now being recalled due to usage challenges and associated risks. Philips has instructed customers to quarantine affected units, with a return and credit process underway. The recall impacts over 2,900 devices, primarily in the U.S. and Europe.