# FDA recall Z-1545-2024

> **Artivion, Inc** · Class II · device recall initiated 2024-03-06.

## Product

CryoValve SG Cryopreserved Pulmonary Human Heart Valve

## Reason for recall

The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.

## Distribution

US Nationwide distribution in the state of Ohio.

## Key facts

- **Recall number:** Z-1545-2024
- **Recalling firm:** Artivion, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-06
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kennesaw, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1545-2024

## Citation

> AI Analytics. FDA recall Z-1545-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1545-2024. Source: US FDA. Licensed CC0.

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