Recall Atlas

Artivion recalls

2 official recalls and safety alerts involving Artivion since 2024-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Artivion or the relevant agency.

  1. 2024-08-14
  2. US
    Drugs & medicalClass II

    Artivion, Inc recalls (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared…

    Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

    FDA · DeviceArtivion, IncUS Nationwide distribution in the states of CA, DC, FL, and NY.Official notice →
  3. 2024-04-24
  4. US
    Drugs & medicalClass II

    Artivion, Inc recalls CryoValve SG Cryopreserved Pulmonary Human Heart Valve

    The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.

    FDA · DeviceArtivion, IncUS Nationwide distribution in the state of Ohio.Official notice →