AtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk
AtriCure is recalling 175 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the agency classification is Class II, which aligns with the 'High' severity criteria for potential serious harm without confirmed fatalities or Class I designation.
Plain-English summary
AtriCure, Inc. is recalling 175 units of the COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-0831-2019.
The recall is due to 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 to facilities in 38 U.S. states and 14 international countries. The distribution list includes states such as Alabama, Arizona, California, Florida, New York, and Texas, as well as international locations including Germany, Italy, France, and the United Kingdom. The recall covers all lots within the expiry date, identified by UDI 00818354012828. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
- Manufacturer
- AtriCure, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 175
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 - 00818354012828 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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