CryoValve SG Pulmonary Human Heart Valve, SGPV00… recallZ-2531-2024 · Artivion, Inc · initiated May 28, 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
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
FDA root cause category: Under Investigation by firm
What the company is doing
The recalling firm issued letters to their Field Representatives on 5/24/2024 or 5/28/2024 for distribution to the consignees via email or hand delivery. The first date consignees were notified was on 5/28/2024 by their Field Representative. The letter provided the details on the tissue the consignee received, the date it was implanted, and the implanting surgeon. The issue was described and it was pointed out there was no indication the impacted tissues were contaminated and unlikely to pose a health risk to the patient. The letter discussed the testing conducted on each allograft and that the identified allograft was reported to have an invalid Post-Processing Sterility test result or a Pre-Processing Culture test result (depending on the consignee letter), which represents a technical failure in the test, not an indication of a positive result. A response form was enclosed for return to acknowledge receipt of the notification.
Recall details
- Recall number
- Z-2531-2024
- Status
- Open, Classified
- Initiated by the company
- May 28, 2024
- Posted by the FDA
- Aug 8, 2024
- Recalling firm
- Artivion, Inc
- Quantity
- 2 valves
- Product code
- OHA
- FDA submissions
- K092021
- Distribution
- US Nationwide distribution in the states of CA, DC, FL, and NY.
Product description
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Code information (models, lots, serial numbers)
Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
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
Other products in the same recall event
The FDA groups related products into one recall event (event 94909).
- Z-2532-2024 · Open, Classified(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) …
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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