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Artivion, Inc

Artivion, Inc Recalls

All product recalls associated with Artivion, Inc.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

May 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–3 of 3 recalls

CryoValve SG Pulmonary Heart Valve (Artivion) – Invalid Test Results (2024)

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

Low

FDAMay 28, 2024Nationwide• Artivion, Inc

CryoPatch SG Pulmonary Hemi-Artery (Artivion) – Invalid Test Results (2024)

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

Low

FDAMay 28, 2024Nationwide• Artivion, Inc

CryoValve SG Heart Valve (Artivion) – Bacterial Contamination (2024)

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

High

FDAMar 6, 2024Nationwide• Artivion, Inc