CLASS II Device recall · Reported 20 Feb 2019 · FDA Enforcement Report

Cobra Fusion 150 Ablation System recalled by AtriCure

AtriCure is recalling Cobra Fusion 150 Ablation System, distributed in 37 states. The recall was initiated on 22 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI - 00818354012828 Lot Numbers - All lots within expiry

Quantity recalled175 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0831-2019
FDA event ID: 81932
Recalling firm: AtriCure, Mason, OH
Classification: Class II
Status: Terminated
Recall initiated: 22 Jan 2019
FDA classified: 14 Feb 2019
Reported: 20 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Jan 2019	Recall initiated by company
14 Feb 2019	Classified by FDA	+23 days
20 Feb 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S

Where it was distributed

AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia

Alabama Arkansas Arizona California Colorado Connecticut Florida Idaho Illinois Indiana Kansas Kentucky Louisiana Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

UDI - 00818354012828 Lot Numbers - All lots within expiry

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 81932

This product is part of a recall event; the main page for the event is Cobra Fusion 150 Ablation System (International Only) recalled.

Reported	Class	Recall	Company	Reason	Where
20 Feb 2019	CLASS II	Cobra Fusion 150 Ablation System (International Only) recalled	AtriCure	Other	37 states
20 Feb 2019	CLASS II	Cobra Fusion 150 Ablation System recalled by AtriCure	AtriCure	Other	37 states
20 Feb 2019	CLASS II	Cobra Fusion 50, Ablation System recalled by AtriCure	AtriCure	Other	37 states

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20 Feb 2019Device	CLASS II	Cobra Fusion 150 Ablation System recalled by AtriCure	AtriCure	Other	37 states

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