Home / Recalls / AtriCure, Inc. / Z-0832-2019

Z-0832-2019 Class II Terminated

Recalled by AtriCure, Inc. — Mason, OH

Recall Details

Product Type
Devices
Report Date
February 20, 2019
Initiation Date
January 22, 2019
Termination Date
May 12, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
765 units

Product Description

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

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.

Distribution Pattern

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

Code Information

UDI - 00818354013016 Lot Numbers - All lots within expiry

Other recalls by AtriCure, Inc.

  • Z-0927-2024 Class II — Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 (November 28, 2023)
  • Z-0928-2024 Class II — Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 (November 28, 2023)
  • Z-1887-2019 Class II — EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product (May 29, 2019)
  • Z-0830-2019 Class II — COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 (January 22, 2019)
  • Z-0829-2019 Class II — COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 (January 22, 2019)
  • Z-0831-2019 Class II — COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S (January 22, 2019)
  • Z-1148-2017 Class II — AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single (November 30, 2016)
  • Z-0653-2017 Class II — COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fus (September 22, 2016)
  • Z-0377-2017 Class II — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is (September 22, 2016)
  • Z-0895-2015 Class II — Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pou (November 21, 2014)