Home / Recalls / AtriCure, Inc. / Z-0653-2017

Z-0653-2017 Class II Terminated

Recalled by AtriCure, Inc. — Mason, OH

FDA device recall Z-0653-2017 was initiated by AtriCure, Inc. on September 22, 2016 and is designated Class II. Reason for recall: Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or st… The recall status is terminated (terminated February 8, 2018). Affected quantity: 5,263.

Recall Details

Product Type
Devices
Report Date
November 30, 2016
Initiation Date
September 22, 2016
Termination Date
February 8, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,263

Product Description

COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).

Reason for Recall

Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.

Distribution Pattern

Worldwide Distribution -- USA, in the following states AL, AR, AZ, CA, CO, CT, GA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI, & VA; and, to the countries of Albania, Australia, Belgium, France, Germany, Ireland, Italy, Norway, Netherlands, Poland, Sweden, Turkey, United Arab Emirates, & United Kingdom.

Code Information

Specifically all lots manufactured prior to February 2016. This information can be identified as the symbol for "date of manufacture" on the product label as: MM-YYYY, e.g. 02-2016 or earlier.

Other recalls by AtriCure, Inc.

  • Z-0928-2024 Class II — Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 (November 28, 2023)
  • Z-0927-2024 Class II — Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 (November 28, 2023)
  • Z-1887-2019 Class II — EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product (May 29, 2019)
  • Z-0832-2019 Class II — COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI (January 22, 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-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)

FDA data resources