Stock: LMAT. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
35
De Novo: 0
PMA approvals
2
40 supplements
Recalled products
84
18 class I
Adverse event reports
1,981
10 deaths reported
LeMaitre Vascular has 84 recalled medical device products in 26 recall actions in the records, 18 of them class I (the most serious kind). The newest recall started on Feb 10, 2026. In 2025 it had 6 recalled products.
35 510(k) clearances, 0 De Novo grants and 2 original PMA approvals for high-risk devices, plus 40 PMA supplements (changes to approved devices). The newest decision was on Sep 4, 2026.
1,981 reports in total: 10 deaths, 271 injuries and 1,663 malfunctions were reported. 257 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 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 3 |
| 2023 |
By product code, all years
All device makers and procedures · LMAT 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 LMAT 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 |
| 4 |
| 2022 | 1 | 0 | 0 | 1 |
| 2020 | 1 | 0 | 0 | 1 |
| 2019 | 2 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 6 |
| 2017 | 0 | 0 | 0 | 1 |
| 2016 | 1 | 0 | 0 | 2 |
| 2015 | 1 | 0 | 0 | 1 |
| 2014 | 2 | 0 | 0 | 7 |
| 2013 | 5 | 0 | 0 | 2 |
| 2012 | 3 | 0 | 0 | 2 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 1 | 0 | 289 | 1 |
| 2025 | 6 | 0 | 257 | 1 |
| 2024 | 1 | 0 | 282 | 3 |
| 2023 | 1 | 0 | 221 | 1 |
| 2022 | 1 | 0 | 141 | - |
| 2021 | 1 | 0 | 129 | 1 |
| 2020 | 1 | 1 | 121 | - |
| 2019 | 1 | 0 | 164 | - |
| 2018 | 2 | 0 | 98 | - |
| 2017 | 12 | 0 | 65 | - |
| 2016 | 10 | 0 | 28 | - |
| 2015 | 14 | 0 | 12 | - |
| 2014 | 0 | 0 | 12 | - |
| 2013 | 19 | 17 | 26 | 1 |
| 2012 | 0 | 0 | 35 | 1 |