Artivion recalls CryoPatch SG Pulmonary Cardiac Hemi-Artery patches due to invalid test results used in approval. Affected units include specific serial numbers and expiration dates.
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Artivion is recalling two types of CryoPatch SG Pulmonary Cardiac Hemi-Artery patches because they were approved and implanted using test results that were invalid. This could pose a risk to patients receiving these patches for heart surgery.
The patches were approved and implanted based on test results that were invalid. This means the patches may not be safe for use in heart surgery, potentially causing complications for patients.
Patients who received the recalled patches during heart surgery are most at risk. The recall affects specific models and serial numbers with known expiration dates.
Check for the model names 'SGPH00' or 'SGP020' with specific serial numbers listed in the recall notice. The expiration dates and unique identifiers (UDI-DI) are also provided for identification.
Review the serial numbers and expiration dates listed in the recall notice to confirm if your patch is affected.
The patches were approved and implanted using test results that were invalid, which could affect their safety during heart surgery.
The affected models are CryoPatch SG Pulmonary Human Cardiac Hemi-Artery (SGPH00) and CryoPatch SG Pulmonary Human Cardiac Branch Patch (SGP020).
Check the serial numbers and expiration dates against the list provided in the recall notice, which includes specific identifiers like UDI-DI.
We’ve drafted a message you can send Artivion to request your refund or repair — edit it as you like.
Subject: Recall Z-2532-2024 — Artivion Artivion Hello, I own a Artivion that is covered by recall Z-2532-2024 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.
