Atricure, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000002974 FEI 3011706110
- Devices
- 562
- Registrations
- EUDAMEDFDA
- FDA recalls
- 132 ongoing
At a glance
EU certificates
9 of 9 in force.
Market reach
- European Union
- EUDAMED actor, 9 certificates
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- AtriCure Europe B.V.NL
What Atricure, Inc. makes
Atricure, Inc. manufactures ligation clips, cardiac radio-frequency ablation system generators, cryosurgical systems using cryogen gas, reusable surgical retractors and blades, instrument trolleys, reusable needle holders, reusable surgical scissors, and reusable flexible endoscopic tissue manipulation forceps. Specific products include the LiV™ Instruments, AtriClip® PRO•V™ LAA Exclusion System, EPi-Sense Guided Coagulation System with VisiTrax, AtriClip FLEX•V, AtriCure System Cart, and Isolator Surgical Ablation System.
The company's devices are classified as Class I, Class II, and Class III and are listed in the FDA UDI registry. Atricure, Inc. is based in the United States.
Catalogue
Search and filter all 562 devicesShowing 1-50 of 562
Company details
- EUDAMED SRN
- US-MF-000002974
- FDA FEI number
- 3011706110
- DUNS number
- 006133784
- EUDAMED status
- Active
- EUDAMED registered name
- AtriCure, Inc.
- Registered address
- 7555, Innovation Way, 45040, Mason, United States
- Website
- www.atricure.com
- Phone
- 866-349-2342
- PRRC contact
- Scott Ehlert
EUDAMED certificates
9 certificates9 valid, 0 expiredMDR 9next expiry 21 Aug 2027
BSI Group The Netherlands B.V. 2797 9 certificates
- MDR 752544 Active
Technical documentation EU MDR
- Issued
- 26 Aug 2025
- Expires
- 16 Dec 2029
- Reason
- Other
- MDR 754861 Active
Technical documentation EU MDR
- Issued
- 26 Aug 2025
- Expires
- 16 Dec 2029
- Reason
- Other
- MDR 752521 Active
Technical documentation EU MDR
- Issued
- 30 Jul 2026
- Expires
- 12 Aug 2029
- Reason
- Change approved
- MDR 754862 Active
Technical documentation EU MDR
- Issued
- 8 Apr 2026
- Expires
- 12 Aug 2029
- Reason
- Other
- MDR 752580 Active
Technical documentation EU MDR
- Issued
- 5 Nov 2024
- Expires
- 13 Mar 2029
- Reason
- Other
- MDR 754787 Active
Technical documentation EU MDR
- Issued
- 15 Jul 2026
- Expires
- 13 Mar 2029
- Reason
- Change approved
- MDR 752587 Active
Technical documentation EU MDR
- Issued
- 11 Aug 2025
- Expires
- 24 Jul 2028
- Reason
- Other
- MDR 752266 Expiring
Quality management system EU MDR
- Issued
- 3 Apr 2026
- Expires
- 21 Aug 2027
- Reason
- Other
- MDR 752541 Expiring
Technical documentation EU MDR
- Issued
- 20 May 2026
- Expires
- 21 Aug 2027
- Reason
- Other
FDA recalls
FDA recall records list 13 recalls initiated by ATRICURE, INC., the earliest on 2013-01-14 and the most recent on 2023-11-28. By recorded status: 2 ongoing and 11 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 5
- 2020 0
- 2021 0
- 2022 0
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 28 Nov 2023 Z-0927-2024 Class II Ongoing 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.
- 28 Nov 2023 Z-0928-2024 Class II Ongoing 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.
2019
- 29 May 2019 Z-1887-2019 Class II 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.
- 22 Jan 2019 Z-0829-2019 Class II 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.
Full distribution text
- 22 Jan 2019 Z-0830-2019 Class II 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.
Full distribution text
- 22 Jan 2019 Z-0831-2019 Class II 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.
Full distribution text
- 22 Jan 2019 Z-0832-2019 Class II 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.
Full distribution text
2016
- 30 Nov 2016 Z-1148-2017 Class II Terminated A complaint of the PRO2 jaw breaking prior to surgery being performed.
Full distribution text
- 22 Sep 2016 Z-0377-2017 Class II Terminated There is a potential for a component failure of the device which could necessitate medical intervention.
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- 22 Sep 2016 Z-0653-2017 Class II 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.
Full distribution text
- 30 Nov 2016 Z-1148-2017 Class II Terminated A complaint of the PRO2 jaw breaking prior to surgery being performed.
Show all 13 recalls
2014
- 21 Nov 2014 Z-0895-2015 Class II 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.
Full distribution text
- 23 Jan 2014 Z-1209-2014 Class II Terminated The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Full distribution text
- 21 Nov 2014 Z-0895-2015 Class II 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.
2013
- 14 Jan 2013 Z-0912-2013 Class II Terminated Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Frequently asked questions
How many devices does ATRICURE, INC. have in the registry?
The registry currently lists 562 devices for ATRICURE, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ATRICURE, INC.'s devices?
Among its 50 most recently registered devices, ATRICURE, INC. has devices listed in EUDAMED (43 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ATRICURE, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ATRICURE, INC.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for ATRICURE, INC.?
FDA recall records list 13 recalls initiated by ATRICURE, INC., the most recent initiated on 28 Nov 2023. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for ATRICURE, INC.?
EUDAMED lists 9 certificates for ATRICURE, INC. (technical documentation; quality management system) under MDR. The most recent was issued on 30 Jul 2026.
What are the newest devices from ATRICURE, INC. in the registry?
The most recently registered devices listed for ATRICURE, INC. include Isolator® Synergy™ EnCompass, Isolator Synergy™ Glidepath™ Tape, Isolater Synergy EnCapture and Isolator Synergy™.