Artivion, Inc: Medical Device Recall in 2024 - (Recall #: Z-2531-2024)

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:

CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.

Product Classification:

Class II

Date Initiated: May 28, 2024

Date Posted: August 14, 2024

Recall Number: Z-2531-2024

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 valves

Code Information:

Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated