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Recall Observatory FDA recall evidence

Device product

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

Z-0927-2024

November 28, 2023

Class II

Product summary

Firm
AtriCure, Inc.
Event
Event 93672
Status
Ongoing
Classification
Class II
Quantity
35
Official record key
device-enforcement:Z-0927-2024

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide. Brazil, Canada, Japan, Taiwan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.