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).

Recall number

Z-0653-2017

Recalling firm

AtriCure, Inc.

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).

Status

Terminated

Initiated

2016-09-22

Posted

not on file

Terminated

2018-02-08

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 and returned as soon as possible.

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, Netherlands, Poland, Sweden, Turkey, United Arab Emirates, & United Kingdom.

Lot, serial or model codes

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.

510(k) numbers

["K113475"]

PMA numbers

not on file

Product code

OCL

Firm FEI

3011706110

Firm city

Mason

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy