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

Recalled August 14, 2024 · FDA recall Z-2532-2024 · Artivion

Hazard

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

Units

2 arteries, 1 patch

Sold at

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

Description

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

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.

Manufacturer(s)

Artivion, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →