Mason, OH, United States
AtriCure, Inc. recalls
3 recalls recorded since 2018, most recently on 28 November 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 November 2023
- Reason
- 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.
- Distribution
- US Nationwide. Brazil, Canada, Japan, Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0927-2024, Z-0928-2024
- Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
- Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Terminated Class II Medical devices
- Recall started
- 29 May 2019
- Terminated
- 4 May 2020
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1887-2019
- EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1c
Terminated Class II Medical devices
- Recall started
- 22 January 2019
- Terminated
- 12 May 2020
- Reason
- 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.
- Distribution
- 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 & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Ku
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0832-2019, Z-0831-2019, Z-0830-2019, Z-0829-2019
- COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
- COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
- COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
- COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.