Class II
Medical Device Recall: Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
AtriCure, Inc. · November 28, 2023
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
US Nationwide. Brazil, Canada, Japan, Taiwan
States Affected
NATIONWIDE
Quantity Affected
35
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0927-2024
Status: ongoing
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