# FDA recall Z-0927-2024

> **AtriCure, Inc.** · Class II · device recall initiated 2023-11-28.

## 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

- **Recall number:** Z-0927-2024
- **Recalling firm:** AtriCure, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-28
- **Report date:** 2024-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mason, OH, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0927-2024. Retrieved 2026-07-29 from https://api.ai-analytics.org/recall/Z-0927-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*