CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syner
FDA device recall Z-2531-2024 · posted 2024-08-08 · Open, Classified
Recall details
- Recalling firm
- Artivion, Inc
- Reason for recall
- Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OHA
- Quantity affected
- 2 valves
- Distribution
- US Nationwide distribution in the states of CA, DC, FL, and NY.
- Date initiated
- 2024-05-28
- Date posted
- 2024-08-08
- Location
- Kennesaw, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (K092021) | Cryolife, Inc. | 2010-05-25 |