Artivion, Inc recalls (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue…

Recall date

May 28, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2532-2024

FDA classification

Class II

Brand / firm

Artivion, Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

(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.