CryoValve SG Heart Valve Recalled for Staphylococcus aureus Contamination
Artivion is recalling one CryoValve SG cryopreserved heart valve contaminated with Staphylococcus aureus, detected during organ donation screening. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of cryopreserved heart valve contaminated with Staphylococcus aureus, a high-risk pathogen. No illnesses or injuries have been reported; contamination was detected during organ donation screening before transplant.
Plain-English summary
Artivion, Inc. is recalling one CryoValve SG cryopreserved pulmonary human heart valve following detection of Staphylococcus aureus in blood cultures performed during the organ donation process.
The recalled unit is Serial ID Number 12578856, UDI-DI Number 00877234000447, with Model/Catalog Number SGPV00 and expiration date April 5, 2028. Distribution was nationwide in the state of Ohio.
Staphylococcus aureus is a high-risk bacterial pathogen capable of causing serious infections in recipients of implanted tissue products. The FDA has classified this as a Class II recall. To date, no illnesses or injuries have been reported in connection with this product.
Patients or healthcare providers with knowledge of this specific valve should contact Artivion immediately or consult with their physician for further guidance.
The recalled product
- Product
- CryoValve SG Cryopreserved Pulmonary Human Heart Valve
- Manufacturer
- Artivion, Inc
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model/Catalog Number: SGPV00
- Serial ID Number: 12578856
- UDI-DI Number: 00877234000447
- Expiration Date 04/05/2028
Distribution
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