Device recall: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's lef

FDA enforcement event 75178 · Class II · initiated 22 Sep 2016 · status Terminated · terminated 15 Feb 2018

DeviceVoluntary: Firm initiated1 product recordMason, OH

FDA enforcement event 75178 is a device recall by AtriCure, Inc. of Mason, OH, initiated 22 Sep 2016 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 15 Feb 2018. 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

"There is a potential for a component failure of the device which could necessitate medical intervention."

Distribution

"Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
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.	298	Class II	Terminated	16 Nov 2016

Context

91%of 2016 device events are Class II1,232 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
29 May 2019	EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation	Device	Class II	1
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
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: "There is a potential for a component failure of the device which could necessitate medical intervention."

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: "Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Feb 2018. "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.