Philips Recalls, Removes, and Discontinues Distribution of Tack Endovascular System

March 6, 2025—The FDA advised this week that Philips is recalling the Tack endovascular systems because of challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant.

The FDA recall notification advised that all customers should stop using the Tack endovascular system immediately and that Philips will no longer distribute the system for use.

According to the notification, the use of the affected product may cause serious adverse health consequences, including short-term risks of partial or complete occlusion, arterial dissection, arterial perforation, and long-term risks of pain, tissue loss, restenosis, the need for bypass surgery, amputation, and death. There have been 20 reported injuries and no reports of death.

On January 10, 2025, Philips Image Guided Therapy Services sent all affected customers an Urgent Medical Device Recall letter alerting them to stop using the device and providing a series of recommended actions to identify, quarantine, and return the affected devices, stated the FDA.

The FDA recall notification is available online here and includes the specific product names/sizes, unique device identifier/catalogue numbers, and batch codes, as well as contact and reporting information.