Artivion recalls CryoValve SG heart valves due to positive Staphylococcus aureus blood cultures in organ donation. Affected units have specific model and serial numbers. Contact for return instructions.
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Artivion is recalling CryoValve SG cryopreserved pulmonary human heart valves after blood cultures from the organ donation process tested positive for Staphylococcus aureus. This poses a risk of infection in recipients since the bacteria can cause serious health issues.
The blood cultures from the organ donation process were positive for Staphylococcus aureus, a type of bacteria that can cause infections. If the valve is used in a recipient, this bacteria could lead to serious infections or complications.
People who received the CryoValve SG heart valve from Artivion are affected. Those with the specific model number SGPV00 and serial number 12578856 are most at risk.
Check for the model number SGPV00 and serial number 12578856 on the valve packaging or label. The product was sold with an expiration date of April 2028.
Verify the model number SGPV00 and serial number 12578856 on the valve packaging or label.
The blood cultures from the organ donation process tested positive for Staphylococcus aureus, which can cause infections in recipients.
The recall record does not specify a remedy or action steps for affected individuals.
Look for the model number SGPV00 and serial number 12578856 on the valve packaging or label.
We’ve drafted a message you can send Artivion to request your refund or repair — edit it as you like.
Subject: Recall Z-1545-2024 — Artivion Artivion Hello, I own a Artivion that is covered by recall Z-1545-2024 from Artivion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
