Stock: BSX. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
1,081
De Novo: 2
PMA approvals
84
6,731 supplements
Recalled products
1,572
142 class I
Adverse event reports
766K
13,362 deaths reported
Boston Scientific has 1,572 recalled medical device products in 459 recall actions in the records, 142 of them class I (the most serious kind). The newest recall started on Aug 24, 2026. In 2025 it had 75 recalled products.
1,081 510(k) clearances, 2 De Novo grants and 84 original PMA approvals for high-risk devices, plus 6,731 PMA supplements (changes to approved devices). The newest decision was on Sep 17, 2026.
766,029 reports in total: 13,362 deaths, 408,553 injuries and 343,167 malfunctions were reported. 75,558 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 | 18 | 0 | 1 | 171 |
| 2025 | 17 | 0 | 0 | 158 |
| 2024 | 16 | 0 | 2 | 211 |
| 2023 |
By product code, all years
All device makers and procedures · BSX 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 BSX 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.
| 26 |
| 1 |
| 1 |
| 249 |
| 2022 | 18 | 0 | 1 | 250 |
| 2021 | 20 | 0 | 1 | 263 |
| 2020 | 21 | 0 | 2 | 352 |
| 2019 | 25 | 0 | 4 | 338 |
| 2018 | 20 | 0 | 1 | 264 |
| 2017 | 26 | 0 | 1 | 407 |
| 2016 | 23 | 1 | 2 | 355 |
| 2015 | 32 | 0 | 7 | 260 |
| 2014 | 43 | 0 | 0 | 339 |
| 2013 | 29 | 0 | 0 | 334 |
| 2012 | 34 | 0 | 2 | 447 |
| 2011 | 6 | 0 | 1 | 55 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 46 | 5 | 54,817 | 725 |
| 2025 | 75 | 48 | 75,558 | 934 |
| 2024 | 150 | 63 | 66,144 | 701 |
| 2023 | 34 | 0 | 59,128 | 505 |
| 2022 | 22 | 0 | 55,344 | 378 |
| 2021 | 68 | 8 | 51,966 | 479 |
| 2020 | 97 | 10 | 48,690 | 465 |
| 2019 | 46 | 0 | 48,864 | 501 |
| 2018 | 26 | 0 | 27,281 | 500 |
| 2017 | 65 | 0 | 21,563 | 542 |
| 2016 | 20 | 1 | 21,218 | 558 |
| 2015 | 65 | 4 | 18,306 | 806 |
| 2014 | 27 | 3 | 17,141 | 433 |
| 2013 | 33 | 0 | 29,269 | 482 |
| 2012 | 19 | 0 | 21,569 | 550 |