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

The U.S. Food and Drug Administration (FDA) has announced that Boston Scientific Corporation is updating use instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters, emphasizing the risk of esophageal fistula and best practices to minimize risk. These updates come following a higher than anticipated number of reports of esophageal injury, specifically atrio-esophageal fistula, after catheter ablation procedures for atrial fibrillation. Keywords: ACC Advocacy, United States Food and Drug