Recall Z-1887-2019— AtriCure, Inc.

Name: FDA recall Z-1887-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-29

Class II · Terminated

Class II FDA medical device recall by AtriCure, Inc., initiated 2019-05-29, terminated 2020-05-04. It names one FDA 510(k) clearance: K142084. Product: 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.. Reason: The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used..

Recalling firm: AtriCure, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-05-29
Terminated: 2020-05-04
Firm location: Mason, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K142084 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAXNcontact Surgical, Inc.·cleared 2014-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.

Data sourced from openFDA. This site is unofficial and independent of the FDA.