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).
This recall has been terminated (originally issued September 22, 2016).
- Company
- Atricure, Inc.
- Recall Initiated
- September 22, 2016
- Terminated
- February 8, 2018
- Recall Number
- Z-0653-2017
- Quantity
- 5,263
- Firm Location
- Mason, OH
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Component design/selection
Action Taken
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.