Stock: MMED. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
66
De Novo: 0
PMA approvals
7
574 supplements
Recalled products
96
4 class I
Adverse event reports
447K
1,651 deaths reported
MiniMed has 96 recalled medical device products in 42 recall actions in the records, 4 of them class I (the most serious kind). The newest recall started on Jul 13, 2026. In 2025 it had 18 recalled products.
66 510(k) clearances, 0 De Novo grants and 7 original PMA approvals for high-risk devices, plus 574 PMA supplements (changes to approved devices). The newest decision was on Aug 5, 2026.
446,632 reports in total: 1,651 deaths, 67,672 injuries and 376,943 malfunctions were reported. 72,446 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 | 6 | 0 | 0 | 14 |
| 2025 | 2 | 0 | 1 | 28 |
| 2024 | 2 | 0 | 0 | 14 |
| 2023 |
By product code, all years
All device makers and procedures · MMED 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 MMED 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.
| 0 |
| 0 |
| 0 |
| 10 |
| 2022 | 1 | 0 | 0 | 20 |
| 2021 | 0 | 0 | 0 | 19 |
| 2020 | 0 | 0 | 0 | 23 |
| 2019 | 0 | 0 | 0 | 75 |
| 2018 | 0 | 0 | 1 | 105 |
| 2017 | 0 | 0 | 0 | 54 |
| 2016 | 1 | 0 | 3 | 45 |
| 2015 | 1 | 0 | 1 | 18 |
| 2014 | 0 | 0 | 0 | 21 |
| 2013 | 0 | 0 | 0 | 18 |
| 2012 | 1 | 0 | 0 | 21 |
| 2011 | 0 | 0 | 0 | 6 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 20 | 0 | 28,207 | 8 |
| 2025 | 18 | 0 | 72,446 | 28 |
| 2024 | 3 | 3 | 48,520 | 19 |
| 2023 | 1 | 0 | 66,234 | 36 |
| 2022 | 12 | 0 | 30,587 | 30 |
| 2021 | 2 | 0 | 4,500 | 20 |
| 2020 | 0 | 0 | 6,338 | 26 |
| 2019 | 16 | 0 | 9,841 | 40 |
| 2018 | 0 | 0 | 13,869 | 234 |
| 2017 | 0 | 0 | 25,858 | 61 |
| 2016 | 1 | 0 | 25,758 | 101 |
| 2015 | 4 | 0 | 37,677 | 136 |
| 2014 | 5 | 0 | 41,539 | 210 |
| 2013 | 3 | 1 | 5,917 | 140 |
| 2012 | 0 | 0 | 3,754 | 56 |