CryoValve SG Pulmonary Human Heart Valve recall
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Why was CryoValve SG Pulmonary Human Heart Valve recalled?
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
- Product
- CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
- Recalling firm
- Artivion, Inc
- Quantity
- 2 valves
- Distribution
- US Nationwide distribution in the states of CA, DC, FL, and NY.
- Recall date
- August 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)