Stock: TNDM. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
24
De Novo: 2
PMA approvals
2
35 supplements
Recalled products
14
6 class I
Adverse event reports
1.4M
316 deaths reported
Tandem Diabetes Care has 14 recalled medical device products in 12 recall actions in the records, 6 of them class I (the most serious kind). The newest recall started on Jul 16, 2026. In 2025 it had 6 recalled products.
24 510(k) clearances, 2 De Novo grants and 2 original PMA approvals for high-risk devices, plus 35 PMA supplements (changes to approved devices). The newest decision was on Apr 24, 2026.
1,374,399 reports in total: 316 deaths, 164,407 injuries and 1,209,648 malfunctions were reported. 253,561 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 | 5 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · TNDM 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 TNDM 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.
| 4 |
| 0 |
| 0 |
| 0 |
| 2022 | 1 | 0 | 0 | 0 |
| 2020 | 3 | 0 | 0 | 0 |
| 2019 | 0 | 2 | 0 | 3 |
| 2018 | 0 | 0 | 1 | 10 |
| 2017 | 0 | 0 | 0 | 7 |
| 2016 | 3 | 0 | 0 | 10 |
| 2015 | 1 | 0 | 1 | 5 |
| 2014 | 2 | 0 | 0 | 0 |
| 2013 | 1 | 0 | 0 | 0 |
| 2011 | 1 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 2 | 0 | 158,312 | 26 |
| 2025 | 6 | 4 | 253,561 | 34 |
| 2024 | 1 | 1 | 237,517 | 30 |
| 2023 | 0 | 0 | 182,060 | 30 |
| 2022 | 2 | 0 | 145,856 | 31 |
| 2021 | 0 | 0 | 104,872 | 13 |
| 2020 | 1 | 0 | 96,092 | 7 |
| 2019 | 0 | 0 | 68,848 | 39 |
| 2018 | 1 | 0 | 36,405 | 23 |
| 2017 | 0 | 0 | 36,969 | 26 |
| 2016 | 0 | 0 | 33,626 | 29 |
| 2015 | 0 | 0 | 14,173 | 19 |
| 2014 | 1 | 1 | 6,031 | 8 |
| 2013 | 0 | 0 | 75 | 1 |
| 2012 | 0 | 0 | 2 | - |