Z-0832-2019Class II

COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI

Name: Z-0832-2019 COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
Creator: AtriCure, Inc.
Published: 2019-01-22
License: https://open.fda.gov/license/

AtriCure, Inc. / initiated 2019-01-22 / Terminated

FDA source

AtriCure, Inc. began a recall of COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI on 2019-01-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0832-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-22
Posted: 2019-02-14
Terminated: 2020-05-12
Recalling firm: AtriCure, Inc.
Product: COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
Product code: OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
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.
FDA root cause: Unknown/Undetermined by firm
Action: On January 22, 2019, AtriCure distributed URGENT Advisory Notices to customers via certified mail. AtriCure is providing modifications to the existing Cobra Fusion Instruction for Use (IFU), to address contributing TE Factors associated with stand-alone off-pump procedures. These are in addition to the warnings and precautions that are present within the current IFU. Modifications to Warnings: When utilizing the Cobra Fusion device in a stand-alone off-pump (without CPB) procedure, the following should be considered: - Physicians should consider a comprehensive anti-coagulation protocol including pre-operative, intra-operative and post-operative anti-coagulation management to prevent potential thromboemboli. Modifications to Precautions: - Post-operative anti-coagulation therapy for protection against thromboemboli is inclusive of the bridging period between the end of the procedure and until effective therapeutic levels of Oral Anticoagulation (OAC) are achieved. Customers Should Take the following Action: - Read and follow the revised Instructions for Use IFU enclosed with the notification letter when using the Cobra Fusion. - Report any post ablation thromboembolic event with the Cobra Fusion, to AtriCure by phone at 1-866-349-2342 (select option 6) or e-mail to [email protected]. - Return the completed Acknowledgement Form. Contact Information: If you have any questions, please contact Rob Cantu, Vice President of Quality at (1-513-644-4245) from 9-6pm ET on Mondays - Fridays. You may also contact customer service at (1-866-349-2342) any time of day, your message will be forwarded to Quality Assurance for review promptly. **Press Release will be issue depended on CDRH comment/review**
Quantity in commerce: 765 units
Distribution: 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
Product codes and lots: UDI - 00818354013016 Lot Numbers - All lots within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0832-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0829-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0830-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0831-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0832-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-14

Product code OCL

K113475Class IIEstech Cobra Adhere Xl 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech / cleared 2012-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)