AtriCure, Inc.
AtriCure, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2025, with 13 FDA device recalls on record.
Top product codes for AtriCure, Inc.
FDA recalls by AtriCure, Inc.
10 most recent of 13- Z-0927-2024 — Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
- Z-0928-2024 — Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
- 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 (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.
- Z-0832-2019 — COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
- Z-0830-2019 — COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
- Z-0831-2019 — COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
- Z-0829-2019 — COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
- Z-1148-2017 — AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box.
- Z-0377-2017 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
- Z-0653-2017 — COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by AtriCure, Inc.
- K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
- K250371 — cryoICE cryoXT cryoablation probe (cryoXT)
- K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM)
- K243157 — AtriCure cryoICE BOX (ACM)
- K234151 — Isolator Synergy EnCapture Ablation System (EMH)
- K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- K233959 — EPi-Ease Epicardial Access Device (EAS)
- K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) +6 more
- K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more
- K221358 — Isolator® Linear Pen (MLP1) +4 more
- K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
- K211311 — AtriCure Isolator® Synergy Surgical Ablation System
- K210293 — AtriClip LAA Exclusion System
- K200697 — AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
- K193162 — EPi-Sense Guided Coagulation System with VisiTrax
- K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
- K191413 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
- K190587 — Coolrail Linear Pen
- K190151 — COBRA Fusion Ablation System
- K183065 — Coolrail Linear Pen
- K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe
- K181474 — ArtiClip LAA Exclusion System
- K180137 — AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
- K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2)
- K180010 — AtriClip FLEX-V
- K173031 — AtriClip LAA Exclusion System with Preloaded PRO·V Clip
- K172742 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
- K163261 — AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
- K163408 — Isolator Multifunctional Linear Pen
- K152337 — cryoFORM cryoICE cryoablation probe
- K160454 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
- K153500 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
- K150996 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
- K142203 — Atricure Cryo Module System; cryoICE cryoablation probe
- K142441 — cryoICE croablation probe
- K142120 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
- K140058 — ATRICURE CRYO MODULE SYSTEM
- K131107 — ATRICLIP GILLINOV-COSGROVE LAA CLIP
- K130521 — ISOLATOR LINEAR PEN
- K122611 — COOLRAIL LINEAR PEN MODEL MCRI
- K122276 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
- K121507 — ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
- K112072 — ATRICURE CRYO MODULE SYSTEM
- K111020 — ATRICURE DISSECTOR
- K111042 — ATRICURE CRYO MODULE
- K110117 — ATRICURE BIPOLAR SYSTEM
- K101174 — ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
- K100501 — MULTIFUNCTIONAL LINEAR PEN
- K093679 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
- K082074 — ATRICURE CRYO1 CRYO-ABLATION PROBE
- K073605 — ATRICURE COOLRAIL LINEAR PEN
- K043579 — ATRICURE BIPOLAR SYSTEM
- K063630 — ATRICURE ABLATION SYSTEM
- K061593 — ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
- K052893 — ATRICURE TRANSPOLAR SYSTEM
- K050459 — ATRICURE ISOLATOR TRANSPOLAR PEN
- K041681 — ATRICURE DISSECTOR
- K020919 — ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
- K011722 — ATRICURE BIPOLAR COAGULATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.