CryoValve SG Cryopreserved Pulmonary Human Heart Valve recallZ-1545-2024 · Artivion, Inc · initiated Mar 6, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Artivion, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1545-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 6, 2024
- Posted by the FDA
- Apr 16, 2024
- Recalling firm
- Artivion, Inc
- Quantity
- 1 unit
- Product code
- OHA
- FDA submissions
- K092021
- Distribution
- US Nationwide distribution in the state of Ohio.
Product description
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Code information (models, lots, serial numbers)
Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CryoValve® SG Pulmonary Human Heart Valve SGPV00Artivion, Inc. · Heart Valve, More Than Minimally Manipulated Allograft3 recalls1 death8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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