Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COBRA FUSION 150 Ablation System Recalled by AtriCure, Inc. Due to There is a potential for patients undergoing ablation...
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 150 Ablation System, Catalog # (REF) 700-001
Quantity: 6176 units
Why Was This Recalled?
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
Where Was This Sold?
This product was distributed to 37 states: AL, AZ, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MS, MO, MT, NE, 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