Recall Z-1545-2024— Artivion, Inc

Name: FDA recall Z-1545-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-06

Class II · Ongoing

Class II FDA medical device recall by Artivion, Inc, initiated 2024-03-06. It names one FDA 510(k) clearance: K092021. Product: CryoValve SG Cryopreserved Pulmonary Human Heart Valve. Reason: The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus..

Recalling firm: Artivion, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-03-06
Firm location: Kennesaw, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K092021 — CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)Cryolife, Inc.·cleared 2010-05-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CryoValve SG Cryopreserved Pulmonary Human Heart Valve

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.