Recall Z-0831-2019— AtriCure, Inc.

Name: FDA recall Z-0831-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-22

Class II · Terminated

Class II FDA medical device recall by AtriCure, Inc., initiated 2019-01-22, terminated 2020-05-12. It names one FDA 510(k) clearance: K113475. Product: COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S. Reason: 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..

Recalling firm: AtriCure, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-22
Terminated: 2020-05-12
Firm location: Mason, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K113475 — ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEMEndoscopic Technologies, Inc. D/B/A Estech·cleared 2012-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.