FDA Device recall Z-0927-2024
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 by Atricure, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0927-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-28 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Atricure |
| Distribution | US |
Product
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
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.
Identifiers
| code_info | UDI-DI: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0927-2024%22
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