Device recall: EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation

FDA enforcement event 83021 · Class II · initiated 29 May 2019 · status Terminated · terminated 4 May 2020

DeviceVoluntary: Firm initiated1 product recordMason, OH

FDA enforcement event 83021 is a device recall by AtriCure, Inc. of Mason, OH, initiated 29 May 2019 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 4 May 2020. Initiation: voluntary: firm initiated. AtriCure, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

AtriCure, Inc., Mason, OH.

Reason for recall

"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."

Distribution

"Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands."

Product records

Recall number	Product	Quantity	Class	Status	Report date
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,…	497	Class II	Terminated	3 Jul 2019

Context

88%of 2019 device events are Class II968 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for AtriCure, Inc.

Initiated	Product (first record)	Type	Class	Records
28 Nov 2023	Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053	Device	Class II	2
22 Jan 2019	COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002	Device	Class II	4
30 Nov 2016	AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a convention	Device	Class II	1
22 Sep 2016	COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Num	Device	Class II	1
22 Sep 2016	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's lef	Device	Class II	1
21 Nov 2014	Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for	Device	Class II	1
23 Jan 2014	Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip	Device	Class II	1
14 Jan 2013	Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using	Device	Class II	1

All 9 events for AtriCure, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.