Stock: PEN. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
87
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
12
5 class I
Adverse event reports
22K
298 deaths reported
Penumbra has 12 recalled medical device products in 9 recall actions in the records, 5 of them class I (the most serious kind). The newest recall started on Jul 24, 2026. In 2020 it had 4 recalled products.
87 510(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 Jun 10, 2026.
21,620 reports in total: 298 deaths, 2,283 injuries and 18,993 malfunctions were reported. 450 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 | 3 | 0 | 0 | 0 |
| 2025 | 3 | 0 | 0 | 0 |
| 2024 | 7 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · PEN 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 PEN 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.
| 2 |
| 0 |
| 0 |
| 0 |
| 2022 | 6 | 0 | 0 | 0 |
| 2021 | 5 | 0 | 0 | 0 |
| 2020 | 8 | 0 | 0 | 0 |
| 2019 | 6 | 0 | 0 | 0 |
| 2018 | 7 | 0 | 0 | 0 |
| 2017 | 4 | 0 | 0 | 0 |
| 2016 | 9 | 0 | 0 | 0 |
| 2015 | 7 | 0 | 0 | 0 |
| 2014 | 3 | 0 | 0 | 0 |
| 2012 | 4 | 0 | 0 | 0 |
| 2011 | 1 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 2 | 0 | 293 | 4 |
| 2025 | 0 | 0 | 450 | 15 |
| 2024 | 0 | 0 | 457 | 19 |
| 2023 | 0 | 0 | 619 | 16 |
| 2022 | 0 | 0 | 654 | 19 |
| 2021 | 0 | 0 | 2,823 | 8 |
| 2020 | 4 | 4 | 2,437 | 23 |
| 2019 | 0 | 0 | 2,475 | 15 |
| 2018 | 0 | 0 | 2,561 | 10 |
| 2017 | 1 | 1 | 2,337 | 3 |
| 2016 | 0 | 0 | 1,909 | 9 |
| 2015 | 0 | 0 | 1,372 | 9 |
| 2014 | 0 | 0 | 943 | 62 |
| 2013 | 0 | 0 | 560 | 23 |
| 2012 | 0 | 0 | 452 | 15 |