RegWardenFDA facility compliance records
Facility

ATRICURE, INC.

9 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 2 recalls; 2016: 3 recalls, 2 inspections; 2018: 3 inspections; 2019: 2 recalls; 2023: 1 recalls1’132’14’155’16’173’182’19’20’21’221’23’24’25’26
  • Recalls (9)
  • Inspections (5)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2023-11-28
    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 t…
  • Class IITerminated2019-05-29
    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.
  • Class IITerminated2019-01-22
    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.
  • Class IITerminated2016-11-30
    A complaint of the PRO2 jaw breaking prior to surgery being performed.
  • Class IITerminated2016-09-22
    There is a potential for a component failure of the device which could necessitate medical intervention.
  • Class IITerminated2016-09-22
    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.
  • Class IITerminated2014-11-21
    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.
  • Class IITerminated2014-01-23
    The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
  • Class IITerminated2013-01-14
    Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.

FDA inspections (5)

  • NAI2018-12-13
    No Action Indicated · Bioresearch Monitoring
  • VAI2018-03-09
    Voluntary Action Indicated · Project Evaluation: Devices
  • NAI2018-03-09
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2016-10-13
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2016-08-29
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ATRICURE, INC. (FEI 3011706110) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011706110-atricure-inc/

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