Cryo Module Accessories Domestic CMA-OUS — Class II medical device recall Z-0927-2024
Ongoing recall by AtriCure, Inc., reported 2024-02-07, distributed nationwide. AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect t
| Recall number | Z-0927-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AtriCure, Inc., Mason, OH, United States |
| Recall initiated | 2023-11-28 |
| Classified | 2024-01-31 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, JP, TW |
| Quantity | 35 |
| UPC / GTIN / UDI-DI | 10840143903038 |
| Lot numbers | 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270 |
| Model numbers | A001053 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0927-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.