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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve SG Cryopreserved Pulmonary Human Heart Valve

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 Class 2 Device Recall CryoValve SG Cryopreserved Pulmonary Human Heart Valvesee related information
Date Initiated by FirmMarch 06, 2024
Date PostedApril 16, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1545-2024
Recall Event ID 94250
510(K)NumberK092021 
Product Classification Heart valve, more than minimally manipulated allograft - Product Code OHA
ProductCryoValve SG Cryopreserved Pulmonary Human Heart Valve
Code Information Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
FEI Number 3001451326
Recalling Firm/
Manufacturer		 Artivion, Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact
678-290-4531
Manufacturer Reason
for Recall		The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe single consignee was notified via email on 03/06/2024 with an amended letter sent on 03/14/2024. The first letter indicated to quarantine and return the affected unit, if not implanted. The consignee was requested to complete and return the response form.
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the state of Ohio.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OHA
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