FDA recall Z-0927-2024

AtriCure, Inc. · Class II · device

Product

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

US Nationwide. Brazil, Canada, Japan, Taiwan

Key facts

Status
Ongoing
Initiation date
2023-11-28
Report date
2024-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mason, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0927-2024