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.
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 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.
See all 4 products in this recall →Related recalls
Same manufacturer · AtriCure, Inc.
See all →- HighTank hose assembly recalled for incorrect material and missing perforations
FDA (Devices) · 2024-02-07
- HighCryo Module Tank Hose Assemblies Recalled for Material and Design Defects
FDA (Devices) · 2024-02-07
- HighAtriCure EPi-Sense Guided Coagulation System Recalled for Compromised Sterile Seal
FDA (Devices) · 2019-07-03
- SevereAtriCure COBRA FUSION 150 Ablation System Recalled for Thromboembolism Risk
FDA (Devices) · 2019-02-20
- SevereAtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk
FDA (Devices) · 2019-02-20
Same hazard · thromboembolism
See all →- SevereCovidien MAHURKAR Dialysis Catheter Recalled for Lumen Occlusion Risk
FDA (Devices) · 2023-08-23
- SevereDialysis catheter recall: excessive lubricant causes center lumen obstruction
FDA (Devices) · 2023-08-23
- HighAtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk
FDA (Devices) · 2019-02-20
- SevereMaquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events
FDA (Devices) · 2015-11-18
- SevereMaquet Universal Frame Recalled Due to Thromboembolic Event Reports
FDA (Devices) · 2015-11-18