Home / Recalls / AtriCure, Inc. / Z-0927-2024

Z-0927-2024 Class II Ongoing

Recalled by AtriCure, Inc. — Mason, OH

Recall Details

Product Type
Devices
Report Date
February 7, 2024
Initiation Date
November 28, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35

Product Description

Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

Reason for Recall

AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.

Distribution Pattern

US Nationwide. Brazil, Canada, Japan, Taiwan

Code Information

UDI-DI: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270

Other recalls by AtriCure, Inc.

  • 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-0831-2019 Class II — COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S (January 22, 2019)
  • Z-0832-2019 Class II — COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI (January 22, 2019)
  • Z-0829-2019 Class II — COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 (January 22, 2019)
  • Z-0830-2019 Class II — COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 (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-0653-2017 Class II — COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fus (September 22, 2016)
  • Z-0895-2015 Class II — Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pou (November 21, 2014)