# FDA recall Z-2532-2024

> **Artivion, Inc** · Class II · device recall initiated 2024-05-28.

## Product

(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and  (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.

## Reason for recall

Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

## Distribution

US Nationwide distribution in the states of CA, DC, FL, and NY.

## Key facts

- **Recall number:** Z-2532-2024
- **Recalling firm:** Artivion, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-28
- **Report date:** 2024-08-14

- **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-2532-2024

## Citation

> AI Analytics. FDA recall Z-2532-2024. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2532-2024. Source: US FDA. Licensed CC0.

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