FDA increases endovascular recall as Philips removes the Tack implant from distribution

Philips, the medical device manufacturer, has made the decision to withdraw its Tack endovascular system, which includes small metal implants designed to support blood vessel repairs, from the market. This decision follows a comprehensive product recall process due to serious concerns over the safety of the device.

The Tack endovascular system is typically used after balloon angioplasty procedures to address tears and dissections in the walls of peripheral arteries, both below and above the knee. However, multiple healthcare providers reported incidents requiring additional procedures to either recover or remove the Tack implants. These cases have led to at least 20 documented patient injuries. As a result, the FDA issued a notice mandating the immediate cessation of the device’s use, and Philips is offering return services and credit options for customers who have purchased the system.

In mid-January, Philips alerted healthcare providers about issues with the Tack system, including deployment difficulties and concerns over the implant’s stability once inside the bloodstream. Key problems identified include the implant’s potential to shift from its original placement and its inability to adequately repair vessel dissections, which could lead to blockages and reduced blood flow to the limbs.

The recall has been classified as a Class I recall by the FDA, the most serious type of recall, impacting around 3,000 units of the Tack system that have been distributed across the U.S. and European markets.

Philips acquired the Tack system as part of its $360 million purchase of Intact Vascular, a move that brought the device under its ownership within the image-guided therapy business. However, due to these safety concerns, the product will now be withdrawn from the market entirely.