Stock: EW. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
165
De Novo: 2
PMA approvals
19
1,165 supplements
Recalled products
191
20 class I
Adverse event reports
104K
7,846 deaths reported
Edwards Lifesciences has 191 recalled medical device products in 77 recall actions in the records, 20 of them class I (the most serious kind). The newest recall started on Mar 27, 2026. In 2025 it had 6 recalled products.
165 510(k) clearances, 2 De Novo grants and 19 original PMA approvals for high-risk devices, plus 1,165 PMA supplements (changes to approved devices). The newest decision was on Sep 16, 2026.
104,244 reports in total: 7,846 deaths, 75,727 injuries and 19,774 malfunctions were reported. 10,480 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 | 5 | 0 | 1 | 59 |
| 2025 | 9 | 0 | 1 | 50 |
| 2024 | 11 | 0 | 1 | 55 |
| 2023 |
By product code, all years
All device makers and procedures · EW 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 EW 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.
| 9 |
| 0 |
| 0 |
| 67 |
| 2022 | 6 | 0 | 1 | 52 |
| 2021 | 4 | 0 | 0 | 39 |
| 2020 | 5 | 1 | 1 | 57 |
| 2019 | 6 | 0 | 0 | 53 |
| 2018 | 5 | 1 | 0 | 88 |
| 2017 | 4 | 0 | 1 | 87 |
| 2016 | 6 | 0 | 1 | 63 |
| 2015 | 6 | 0 | 1 | 44 |
| 2014 | 10 | 0 | 1 | 73 |
| 2013 | 7 | 0 | 0 | 98 |
| 2012 | 7 | 0 | 1 | 73 |
| 2011 | 2 | 0 | 1 | 5 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 1 | 0 | 7,998 | 645 |
| 2025 | 6 | 6 | 10,480 | 621 |
| 2024 | 0 | 0 | 9,918 | 674 |
| 2023 | 10 | 0 | 8,827 | 580 |
| 2022 | 4 | 0 | 7,157 | 500 |
| 2021 | 14 | 0 | 6,349 | 440 |
| 2020 | 1 | 0 | 5,468 | 420 |
| 2019 | 13 | 8 | 5,058 | 154 |
| 2018 | 6 | 4 | 5,634 | 157 |
| 2017 | 3 | 1 | 4,594 | 166 |
| 2016 | 0 | 0 | 3,951 | 184 |
| 2015 | 7 | 0 | 3,706 | 217 |
| 2014 | 4 | 0 | 3,335 | 225 |
| 2013 | 14 | 1 | 3,241 | 283 |
| 2012 | 12 | 0 | 2,523 | 155 |