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U.S. Department of Health and Human Services

Class 2 Device Recall COBRA Fusion Ablation System

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  Class 2 Device Recall COBRA Fusion Ablation System see related information
Date Initiated by Firm September 22, 2016
Create Date November 22, 2016
Recall Status1 Terminated 3 on February 08, 2018
Recall Number Z-0653-2017
Recall Event ID 75373
510(K)Number K113475  
Product Classification Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue - Product Code OCL
Product COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003.

Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
Code Information Specifically all lots manufactured prior to February 2016. This information can be identified as the symbol for "date of manufacture" on the product label as: MM-YYYY, e.g. 02-2016 or earlier.
Recalling Firm/
Manufacturer		 AtriCure, Inc.
7555 Innovation Way
Mason OH 45040-9695
For Additional Information Contact
513-755-4563
Manufacturer Reason
for Recall		 Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.
FDA Determined
Cause 2		 Component design/selection
Action An Urgent: COBRA Fusion Ablation System Advisory Notification Letter with Acknowledgement Form was sent to all users. The letter described the issue and identified the affected device. Customers were asked to examine their inventory and determine if any affected product was on hand. All users, including those that the device may have been further distributed should be notified with a copy of the letter. Customers are to contact AtriCure customer service at 1-866-349-2342, and select option 6 to return any affected devices. The Device Notification Acknowledgement Form should be completed and returned as soon as possible.
Quantity in Commerce 5,263
Distribution Worldwide Distribution -- USA, in the following states AL, AR, AZ, CA, CO, CT, GA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI, & VA; and, to the countries of Albania, Australia, Belgium, France, Germany, Ireland, Italy, Norway, Netherlands, Poland, Sweden, Turkey, United Arab Emirates, & United Kingdom.
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 = ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
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