Kennesaw, GA, United States
Artivion, Inc recalls
2 recalls recorded since 2018, most recently on 28 May 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 May 2024
- Reason
- Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- Distribution
- US Nationwide distribution in the states of CA, DC, FL, and NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2532-2024, Z-2531-2024
- (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Br
- CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Ongoing Class II Medical devices
- Recall started
- 6 March 2024
- Reason
- The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- Distribution
- US Nationwide distribution in the state of Ohio.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1545-2024
- CryoValve SG Cryopreserved Pulmonary Human Heart Valve
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.