Stock: PODD. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
25
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
21
10 class I
Adverse event reports
330K
356 deaths reported
Insulet has 21 recalled medical device products in 15 recall actions in the records, 10 of them class I (the most serious kind). The newest recall started on May 20, 2026. In 2025 it had 2 recalled products.
25 510(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 29, 2026.
330,403 reports in total: 356 deaths, 38,272 injuries and 291,039 malfunctions were reported. 65,362 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 | 1 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · PODD 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 PODD 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.
| 3 |
| 0 |
| 0 |
| 0 |
| 2022 | 5 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 |
| 2019 | 3 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 |
| 2016 | 1 | 0 | 0 | 0 |
| 2014 | 1 | 0 | 0 | 0 |
| 2013 | 1 | 0 | 0 | 0 |
| 2012 | 1 | 0 | 0 | 0 |
| 2011 | 1 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 4 | 4 | 62,918 | 100 |
| 2025 | 2 | 0 | 65,362 | 30 |
| 2024 | 0 | 0 | 52,136 | 17 |
| 2023 | 2 | 1 | 37,200 | 26 |
| 2022 | 2 | 1 | 24,832 | 20 |
| 2021 | 1 | 0 | 23,371 | 11 |
| 2020 | 3 | 0 | 20,379 | 28 |
| 2019 | 0 | 0 | 14,084 | 45 |
| 2018 | 1 | 0 | 9,199 | 26 |
| 2017 | 0 | 0 | 6,740 | 10 |
| 2016 | 0 | 0 | 4,257 | 2 |
| 2015 | 4 | 4 | 2,833 | 15 |
| 2014 | 0 | 0 | 1,995 | 11 |
| 2013 | 2 | 0 | 1,658 | 11 |
| 2012 | 0 | 0 | 687 | 1 |