Stock: LIVN. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
94
De Novo: 0
PMA approvals
3
240 supplements
Recalled products
236
1 class I
Adverse event reports
74K
3,531 deaths reported
LivaNova has 236 recalled medical device products in 80 recall actions in the records, 1 of them class I (the most serious kind). The newest recall started on Jan 3, 2025. In 2024 it had 3 recalled products.
94 510(k) clearances, 0 De Novo grants and 3 original PMA approvals for high-risk devices, plus 240 PMA supplements (changes to approved devices). The newest decision was on Aug 12, 2026.
73,803 reports in total: 3,531 deaths, 23,502 injuries and 44,450 malfunctions were reported. 1,919 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 | 2 | 0 | 1 | 4 |
| 2025 | 6 | 0 | 0 | 6 |
| 2024 | 6 | 0 | 0 | 3 |
| 2023 |
By product code, all years
All device makers and procedures · LIVN 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 LIVN 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.
| 4 |
| 0 |
| 0 |
| 5 |
| 2022 | 1 | 0 | 0 | 3 |
| 2021 | 4 | 0 | 0 | 1 |
| 2020 | 4 | 0 | 0 | 6 |
| 2019 | 2 | 0 | 0 | 7 |
| 2018 | 3 | 0 | 0 | 3 |
| 2017 | 3 | 0 | 0 | 9 |
| 2016 | 0 | 0 | 0 | 18 |
| 2015 | 2 | 0 | 0 | 14 |
| 2014 | 3 | 0 | 0 | 6 |
| 2013 | 5 | 0 | 0 | 13 |
| 2012 | 7 | 0 | 0 | 10 |
| 2011 | 1 | 0 | 0 | 9 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 890 | 26 |
| 2025 | 2 | 0 | 1,919 | 64 |
| 2024 | 3 | 0 | 2,339 | 97 |
| 2023 | 1 | 0 | 2,717 | 133 |
| 2022 | 0 | 0 | 2,599 | 67 |
| 2021 | 2 | 0 | 2,953 | 71 |
| 2020 | 31 | 0 | 3,340 | 114 |
| 2019 | 7 | 1 | 4,888 | 143 |
| 2018 | 11 | 0 | 4,710 | 161 |
| 2017 | 39 | 0 | 4,457 | 317 |
| 2016 | 9 | 0 | 4,906 | 289 |
| 2015 | 10 | 0 | 4,780 | 260 |
| 2014 | 2 | 0 | 4,692 | 307 |
| 2013 | 6 | 0 | 4,623 | 155 |
| 2012 | 26 | 0 | 4,424 | 149 |