AtriCure COBRA FUSION 150 Ablation System Recalled for Thromboembolism Risk
AtriCure is recalling 765 units of the COBRA FUSION 150 Ablation System due to a potential elevated risk of thromboembolism during specific off-pump procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a significant injury risk (thromboembolism), which aligns with the rubric criteria for a Severe severity score.
Plain-English summary
AtriCure, Inc. is recalling 765 units of the COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is issued because there is a potential for patients undergoing ablation to experience an elevated risk for thromboembolism (TE). This risk is specifically associated with stand-alone off-pump procedures where cardiopulmonary bypass (CPB) was not utilized.
The affected units were distributed in the United States to the following states: AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI. The products were also distributed internationally in Germany, Italy, the Netherlands, France, Austria, the United Kingdom, Poland, the Czech Republic, the United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium, and Latvia. The UDI for the product is 00818354013016, and the recall includes all lots within expiry.
The recalled product
- Product
- COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
- Manufacturer
- AtriCure, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 765
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI - 00818354013016 Lot Numbers - All lots within expiry
Distribution
Part of a larger recall action
This product is one of 4 recalled by AtriCure, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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