Recall Z-0831-2019 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
AtriCure, Inc.
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
| Date | Jan 22, 2019 |
| Status | Terminated |
| 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. |
| 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 incl |
| Quantity | 175 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, Kuwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM Endoscopic Technologies, Inc. D/B/A Estech, Mar 20, 2012 |