AtriCure Recalls COBRA FUSION 50 Ablation Systems Due to Thromboembolism Risk
AtriCure is recalling 1,288 COBRA FUSION 50 Ablation Systems because patients may face an elevated risk of thromboembolism during specific off-pump procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk medical device with a potential for serious injury (thromboembolism) but the source text does not report any actual illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AtriCure, Inc. is recalling 1,288 units of the COBRA FUSION 50 Ablation System, Catalog # (REF) 700-002. The recall covers all lots within expiry and includes the UDI 00818354012811. The devices were distributed to 37 U.S. states and 14 international countries, including Germany, Italy, and the United Kingdom.
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 source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare providers and patients should contact AtriCure, Inc. for further instructions regarding the return or replacement of the affected devices. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
- Manufacturer
- AtriCure, Inc.
- Category
- Medical Device — Ablation System
- Hazard
- Affected units
- 1,288
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 - 00818354012811 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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