Stock: IRMD. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
7
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
3
1 class I
Adverse event reports
227
9 deaths reported
IRADIMED has 3 recalled medical device products in 3 recall actions in the records, 1 of them class I (the most serious kind). The newest recall started on Feb 24, 2023. In 2013 it had 1 recalled products.
7 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on May 28, 2025.
227 reports in total: 9 deaths, 39 injuries and 165 malfunctions were reported. 20 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 |
|---|---|---|---|---|
| 2025 | 1 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 |
| 2017 |
By product code, all years
All device makers and procedures · IRMD 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 IRMD 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.
| 1 |
| 0 |
| 0 |
| 0 |
| 2016 | 1 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 10 | 3 |
| 2025 | 0 | 0 | 20 | 3 |
| 2024 | 0 | 0 | 13 | - |
| 2023 | 1 | 0 | 30 | - |
| 2022 | 0 | 0 | 9 | 1 |
| 2021 | 0 | 0 | 7 | - |
| 2020 | 0 | 0 | 5 | 1 |
| 2019 | 0 | 0 | 12 | - |
| 2018 | 0 | 0 | 5 | - |
| 2017 | 0 | 0 | 5 | - |
| 2016 | 0 | 0 | 5 | - |
| 2015 | 0 | 0 | 15 | - |
| 2014 | 0 | 0 | 18 | - |
| 2013 | 1 | 1 | 19 | 1 |
| 2012 | 1 | 0 | 32 | - |