EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Pr ...



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.
Components:
Units Affected:    497
Recall Date:    May 29, 2019
Mfg:
AtriCure, Inc.
Mfg Country:
United States
Recall ID:    83021
Product ID:    173344
Enforcement Date:    Jul 3, 2019
Termination Date:    May 4, 2020
Last Published:    May 4, 2020

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Emert Number:    Z-1887-2019
Emert Status:    Terminated