Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

AtriCure medical devices: approvals, recalls and adverse events

Stock: ATRC. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

33 supplements

Recalled products

0 class I

Adverse event reports

1,053

90 deaths reported

How many recalls does AtriCure have?

AtriCure has 13 recalled medical device products in 9 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Nov 28, 2023. In 2019 it had 5 recalled products.

How many medical devices has AtriCure had cleared or approved?

59 510(k) clearances, 0 De Novo grants and 2 original PMA approvals for high-risk devices, plus 33 PMA supplements (changes to approved devices). The newest decision was on May 6, 2026.

How many adverse event reports name AtriCure devices?

1,053 reports in total: 90 deaths, 590 injuries and 366 malfunctions were reported. 57 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	0	0	0	2
2025	3	0	0	5
2024	4	0	0	2
2023

Newest clearances and approvals

Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
K252056 · 510(k) clearance · Jul 24, 2025
cryoICE cryoXT cryoablation probe (cryoXT)
K250371 · 510(k) clearance · Apr 10, 2025
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · 510(k) clearance · Jan 15, 2025
AtriCure cryoICE BOX (ACM)
K243157 · 510(k) clearance · Oct 29, 2024
Isolator Synergy EnCapture Ablation System (EMH)
K234151 · 510(k) clearance · Aug 27, 2024
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125 · 510(k) clearance · Jul 29, 2024
EPi-Ease Epicardial Access Device (EAS)
K233959 · 510(k) clearance · Feb 13, 2024
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (...
K233407 · 510(k) clearance · Nov 2, 2023
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
K233170 · 510(k) clearance · Oct 26, 2023
Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)

Devices with the most adverse event reports

By product code, all years

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (OCL, class 2)418
Clip, Implantable (FZP, class 2)210
Left Atrial Appendage Clip, Implantable (PZX, class 2)82
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation (OCM, class 3)69
Electrosurgical, Cutting & Coagulation & Accessories (GEI, class 2)59
Lamp, Surgical (FTD, class 2)42
Device, Surgical, Cryogenic (GXH, class 2)40
Unit, Cryosurgical, Accessories (GEH, class 2)35
Instruments, Surgical, Cardiovascular (DWS, class 1)31

All device makers and procedures · ATRC stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to ATRC with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Reports	Deaths
2026	0	44	4
2025	0	57	4
2024	0	76	6
2023	2	59	3
2022	0	49	4
2021	0	59	7
2020	0	46	1
2019	5	72	10
2018	0	122	10
2017	0	119	11
2016	3	162	11
2015	0	51	5
2014	2	13	3
2013	1	21	4
2012	0	11	1

Newest recalls

Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Class II · Nov 28, 2023 · AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies we
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Class II · Nov 28, 2023 · AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies we
EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax
Class II · May 29, 2019 · 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.
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
Class II · Jan 22, 2019 · There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypas
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Class II · Jan 22, 2019 · There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypas
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Class II · Jan 22, 2019 · There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypas
COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
Class II · Jan 22, 2019 · There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypas
AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed poly
Class II · Nov 30, 2016 · A complaint of the PRO2 jaw breaking prior to surgery being performed.
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-0
Class II · Sep 22, 2016 · Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent imp
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage,
Class II · Sep 22, 2016 · There is a potential for a component failure of the device which could necessitate medical intervention.