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FDA Update: Philips Recalls Tack Endovascular Systems

The U.S. Food and Drug Administration (FDA) announced on March 3 that Philips is removing and discontinuing distribution of the Tack Endovascular System due to challenges necessitating additional procedures to retrieve or remove the implant.

The FDA advises that "all customers should stop using the Tack Endovascular System immediately," and that use of the device may cause severe short-term adverse health effects, such as arterial occlusion, dissection or perforation, and more long-term impacts like pain, tissue loss, restenosis, the need for bypass surgery, amputation or death.

Access the agency website for more information.

Keywords: United States Food and Drug Administration, Prostheses and Implants, ACC Advocacy