Class II — AtriCure, Inc.
| Recalling firm | ATRICURE, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 |
| Quantity | 1 |
| Distribution | US Nationwide. Brazil, Canada, Japan, Taiwan |
| Initiated | 2023-11-28 |
| Classified | 2024-01-31 |
| Recall number | Z-0928-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AtriCure, Inc. (Z-0928-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93672/
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