Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COBRA Fusion 50 Ablation System Recalled by AtriCure, Inc. Due to Due to product design and process control, part...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AtriCure, Inc. directly.
Affected Products
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).
Quantity: 5,263
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 37 states: AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI
About AtriCure, Inc.
AtriCure, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report