AtriCure, Inc.: Medical Device Recalls in 2019

According to to data from the FDA, there were 5 medical device recalls made by AtriCure, Inc. in 2019. See the details of the recalls below.

You can see similar recalls for other firms.

• COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
• COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
• COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
• COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
• EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.