AtriCure, Inc. Recalls
2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (2)
- Class II
November 28, 2023
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
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.
- Class II
November 28, 2023
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
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.
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