Class 2 Device Recall EPiSense Guided Coagulation System with VisiTrax

• Date Initiated by Firm: May 29, 2019
• Create Date: June 26, 2019
• Recall Status: Terminated on May 04, 2020
• Recall Number: Z-1887-2019
• Recall Event ID: 83021
• 510(K)Number: K142084
• Product Classification: Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue - Product Code OCL
• 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.
• Code Information: Lots 70638, 71332, 89208, 89938, 90624
• Recalling Firm/ Manufacturer: AtriCure, Inc.; 7555 Innovation Way; Mason OH 45040-9695
• For Additional Information Contact: Customer Service; 866-349-2342
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: On May 29, 2019, the firm notified customers of the recall via Urgent Advisory Notice. Customers were asked to take the following actions: " Immediately quarantine any affected product as identified within this Advisory Notice. " Contact AtriCure product complaints by phone at 1-866-349-2342 (select option 6) or e-mail to pcomplaints@atricure.com to request a Return Goods Authorization (RGA). " Return the attached Acknowledgement Form. See Attachment B. The acknowledgement form must be completed and returned even if product is not on hand by selecting the second option. " Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions, please contact Rob Cantu, Vice President of Quality at (1-513-644-4245) from 9-6pm ET on Mondays - Fridays. You may also contact customer service at (1-866-349-2342) any time of day, your message will be forwarded to Quality Assurance for review promptly. This advisory issue will also be posted on AtriCures website at www.atricure.com/products.
• Quantity in Commerce: 497
• Distribution: Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OCL and Original Applicant = NCONTACT SURGICAL, INC.