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ATRICURE, INC.

United States·US-MF-000002974

Last updated September 17, 2026

Information

Country: United States
Address: 7555, Innovation Way, Mason, United States
Website: www.atricure.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 866-349-2342
PRRC Contact: Scott Ehlert
EUDAMED SRN: US-MF-000002974
FDA FEI Number: 3011706110
DUNS Number: 006133784

Catalogue (441)

Page 6 of 9

Device	Model / Reference	Registries	Class	Status
AtriCure cryoICE cryoFORM Cryoablation System (CRYOF)	CRYOF	FDA UDI	Class II	Active
Isolator Surgical Ablation System	MAX1	FDA UDI	Class II	Active
AtriClip™ LAA Exclusion System	PRO150	FDA UDI	Class II	Active
SureCUT	5001	FDA UDI	Class I	Active
AtriCure SI Retractor Blade	001-400-192	FDA UDI	Class I	Active
AtriCure cryoICE Cryoablation System (CRYO3)	CRYO3	FDA UDI	Class II	Active
Isolator Surgical Ablation System	GPT100	FDA UDI	Class I	Active
LiV™ Instruments	001-340-7824L	FDA UDI	Class I	Active
Fusion Ablation System	001-700-001S	FDA UDI	Class II	Active
AtriClip FLEX•V	ACHV50	FDA UDI	Class II	Active
AtriClip® FLEX Gillinov-Cosgrove LAA Exclusion System	ACH245	FDA UDI	Class II	Active
AtriClip™ LAA Exclusion System	LAA045	FDA UDI	Class II	Active
AtriClip® Gillinov-Cosgrove LAA Exclusion System	LAA050	FDA UDI	Class II	Active
Synergy™ Ablation System	OSL2	FDA UDI	Class III	Active
LiV™ Instruments	001-340-7475	FDA UDI	Class I	Active
AtriClip® LAA Exclusion System	PRO250	FDA UDI	Class II	Active
LiV™ Instruments	001-300-700	FDA UDI	Class I	Active
AtriCure Isolator Synergy EnCompass Clamp and Guide System	OSH	FDA UDI	Class II	Active
AtriCure cryoICE cryoSPHERE Cryoablation System	CRYOS-L	FDA UDI	Class II	Active
AtriCure SI Retractor Blade	001-400-173	FDA UDI	Class I	Active
Isolator Surgical Ablation System	EMR2	FDA UDI	Class II	Active
AtriClip PRO-Mini LAA Exclusion System	PROM45	FDA UDI	Class II	Active
LiV™ Instruments	001-340-7800S	FDA UDI	Class I	Active
LiV™ Instruments	001-340-7850	FDA UDI	Class I	Active
AtriCure Atrial Rake	001-400-441	FDA UDI	Class I	Active
AtriClip™ LAA Exclusion System	ACH150	FDA UDI	Class II	Active
SofTIP	Long	FDA UDI	Class II	Active
LiV™ Instruments	001-340-7800L	FDA UDI	Class I	Active
AtriClip™ LAA Exclusion System	ACH140	FDA UDI	Class II	Active
AtriClip™ LAA Exclusion System	LAA035	FDA UDI	Class II	Active
AtriClip® Flex-V® LAA Exclusion System	ACHV50	FDA UDI	Class II	Active
AtriClip™ LAA Exclusion System	LAA050	FDA UDI	Class II	Active
LiV™ Instruments	001-340-7803	FDA UDI	Class I	Active
LiV™ Instruments	001-340-7803S	FDA UDI	Class I	Active
AtriClip™ LAA Exclusion System	PRO135	FDA UDI	Class II	Active
LiV™ Instruments	001-340-7806S	FDA UDI	Class I	Active
cryoICE Cryoablation System	CRYO2	FDA UDI	Class II	Active
LiV™ Instruments	001-340-7862	FDA UDI	Class I	Active
Synergy™ Ablation System	GPT300	FDA UDI	Class I	Active
AtriCure SI Retractor Blade	001-400-171	FDA UDI	Class I	Active
AtriClip™ LAA Exclusion System	PRO135	FDA UDI	Class II	Active
AtriCure SI Retractor Blade	001-400-191	FDA UDI	Class I	Active
AtriClip® LAA Exclusion System	PRO240	FDA UDI	Class II	Active
cryoICE Cryoablation System	CRYO2	FDA UDI	Class II	Active
ClearView MV Atrial Depressor	001-400-005	FDA UDI	Class II	Active
AtriClip™ LAA Exclusion System	PRO140	FDA UDI	Class II	Active
AtriClip® FLEX-Mini™ LAA Exclusion System	ACHM40	FDA UDI	Class II	Active
EPi-Sense Guided Coagulation System with VisiTrax	CDK-1413	FDA UDI	Class II	Active
FindrWIRZ	4005	FDA UDI	Class II	Active
AtriClip™ LAA Exclusion System	ACH235	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

AtriCure Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 28, 2023	Z-0927-2024	—	open, classified	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.
Nov 28, 2023	Z-0928-2024	—	open, classified	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.
May 29, 2019	Z-1887-2019	—	terminated	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.
Jan 22, 2019	Z-0831-2019	—	terminated	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.
Jan 22, 2019	Z-0830-2019	—	terminated	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.
Jan 22, 2019	Z-0832-2019	—	terminated	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.
Jan 22, 2019	Z-0829-2019	—	terminated	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.
Nov 30, 2016	Z-1148-2017	—	terminated	A complaint of the PRO2 jaw breaking prior to surgery being performed.
Sep 22, 2016	Z-0377-2017	—	terminated	There is a potential for a component failure of the device which could necessitate medical intervention.
Sep 22, 2016	Z-0653-2017	—	terminated	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 impairment or damage to body function or structure.
Nov 21, 2014	Z-0895-2015	—	terminated	Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.
Jan 23, 2014	Z-1209-2014	—	terminated	The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Jan 14, 2013	Z-0912-2013	—	terminated	Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.