Home / Recalls / Artivion, Inc / Z-2532-2024

Z-2532-2024 Class II Ongoing

Recalled by Artivion, Inc — Kennesaw, GA

Recall Details

Product Type: Devices
Report Date: August 14, 2024
Initiation Date: May 28, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 arteries, 1 patch

Product Description

(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 Pattern

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

Code Information

(1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485.