Artivion, Inc: Medical Device Recall in 2024 - (Recall #: Z-1545-2024)

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 Cryopreserved Pulmonary Human Heart Valve

Product Classification:

Class II

Date Initiated: March 6, 2024

Date Posted: April 24, 2024

Recall Number: Z-1545-2024

Event ID: 94250

Reason for Recall:

The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028

Distribution Pattern:

US Nationwide distribution in the state of Ohio.

Voluntary or Mandated:

Voluntary: Firm initiated