Recall Z-0653-2017 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
AtriCure, Inc.
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).
| Date | Sep 22, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 a |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM Endoscopic Technologies, Inc. D/B/A Estech, Mar 20, 2012 |