AtriCure Recalls

8 recalls on record in the United States

medical: 8
medical Class II
2017-02-15

AtriCure, Inc. recalls AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgr

A complaint of the PRO2 jaw breaking prior to surgery being performed.

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medical Class II
2024-02-07

AtriCure, Inc. recalls Cryo Module Accessories Domestic CMA-OUS, Product Catalog

AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.

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medical Class II
2024-02-07

AtriCure, Inc. recalls Packaged, Tank Hose Assembly CMA-US, Product Catalog Number

AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.

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medical Class II
2019-07-03

AtriCure, Inc. recalls EPi-Sense Guided Coagulation System with Visitrax, MOdel No.

The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.

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medical Class II
2019-02-20

AtriCure, Inc. recalls COBRA FUSION 150 Ablation System (International Only), Catal

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.

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medical Class II
2019-02-20

AtriCure, Inc. recalls COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S

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.

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medical Class II
2019-02-20

AtriCure, Inc. recalls COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001

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.

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medical Class II
2019-02-20

AtriCure, Inc. recalls COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002

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.

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