FDA Medical Device Recalls (openFDA)
Artivion, Inc: CryoValve SG Cryopreserved Pulmonary Human Heart Valve
- Recall number
- Z-1545-2024
- Recalling firm
- Artivion, Inc
- Product
- CryoValve SG Cryopreserved Pulmonary Human Heart Valve
- Status
- Open, Classified
- Initiated
- 2024-03-06
- Posted
- 2024-04-16
- Terminated
- not on file
- Reason
- The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- Root cause
- Under Investigation by firm
- Action
- The 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
- 1 unit
- Distribution
- US Nationwide distribution in the state of Ohio.
- Lot, serial or model codes
- Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
- 510(k) numbers
- ["K092021"]
- PMA numbers
- not on file
- Product code
- OHA
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28