Stock: AORT. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
14
De Novo: 0
PMA approvals
3
74 supplements
Recalled products
100
0 class I
Adverse event reports
1,825
206 deaths reported
Artivion has 100 recalled medical device products in 59 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on May 28, 2024. In 2021 it had 1 recalled products.
14 510(k) clearances, 0 De Novo grants and 3 original PMA approvals for high-risk devices, plus 74 PMA supplements (changes to approved devices). The newest decision was on Jul 15, 2026.
1,825 reports in total: 206 deaths, 1,306 injuries and 92 malfunctions were reported. 32 reports were received in 2025. A report alone does not show that the device caused the problem.
Last 15 years
| Year | 510(k) clearance | De Novo grant | PMA approval | PMA supplement |
|---|---|---|---|---|
| 2026 | 0 | 0 | 1 | 1 |
| 2025 | 1 | 0 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 1 |
| 2022 |
By product code, all years
All device makers and procedures · AORT stock page
Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to AORT with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.
| 0 |
| 0 |
| 0 |
| 2 |
| 2021 | 0 | 0 | 0 | 3 |
| 2019 | 1 | 0 | 0 | 6 |
| 2018 | 0 | 0 | 0 | 4 |
| 2017 | 2 | 0 | 0 | 7 |
| 2016 | 0 | 0 | 0 | 8 |
| 2015 | 0 | 0 | 0 | 3 |
| 2014 | 1 | 0 | 0 | 2 |
| 2013 | 1 | 0 | 0 | 2 |
| 2012 | 1 | 0 | 0 | 6 |
| 2011 | 0 | 0 | 0 | 1 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 20 | 4 |
| 2025 | 0 | 0 | 32 | 3 |
| 2024 | 3 | 0 | 33 | 3 |
| 2023 | 0 | 0 | 32 | - |
| 2022 | 0 | 0 | 56 | 2 |
| 2021 | 1 | 0 | 58 | 8 |
| 2020 | 2 | 0 | 69 | 18 |
| 2019 | 1 | 0 | 82 | 5 |
| 2018 | 4 | 0 | 61 | 5 |
| 2017 | 1 | 0 | 53 | 7 |
| 2016 | 1 | 0 | 96 | 11 |
| 2015 | 1 | 0 | 352 | 76 |
| 2014 | 2 | 0 | 53 | 1 |
| 2013 | 1 | 0 | 50 | 6 |
| 2012 | 0 | 0 | 38 | 6 |