Artivion, Inc: Medical Device Recall in 2024 - (Recall #: Z-2532-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 28, 2024

Date Posted: August 14, 2024

Recall Number: Z-2532-2024

Event ID: 94909

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2 arteries, 1 patch

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated