Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-03 | 0 | 2 |
| 2019-09 | 0 | 2 |
| 2019-11 | 0 | 2 |
| 2019-12 | 0 | 1 |
| 2020-05 | 0 | 1 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 2 |
| 2021-07 | 0 | 1.5 |
| 2021-08 | 0 | 2 |
| 2021-10 | 0 | 6 |
| 2021-11 | 0 | 2 |
| 2022-02 | 0 | 2 |
| 2022-03 | 0 | 1.5 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 2 |
| 2022-07 | 0 | 4 |
| 2022-08 | 0 | 1.75 |
| 2022-09 | 0 | 1.33 |
| 2022-10 | 0 | 4 |
| 2022-11 | 0 | 4 |
| 2022-12 | 0 | 3.5 |
| 2023-01 | 0 | 1 |
| 2023-03 | 0 | 3.33 |
| 2023-05 | 0 | 2 |
| 2023-08 | 0 | 2 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 4 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 2 |
| 2024-01 | 0 | 2 |
| 2024-02 | 0 | 2 |
| 2024-07 | 0 | 2 |
| 2024-10 | 0 | 2 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 1 |
| 2025-07 | 0 | 4 |
| 2025-08 | 0 | 2 |
| 2025-12 | 0 | 4 |
| 2026-01 | 0 | 3 |
| 2026-02 | 0 | 2 |
| 2026-03 | 1 | 1.5 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-18 | 3012495575-2026-00001 | Malfunction | Available | exact di |
Regulatory clearances
Predicate lineage
- K240664
Cited as predicate by: K243945
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-12-14 | NAI | No action indicated | SurGenTec, LLC | 0 |
| 2022-12-14 | NAI | No action indicated | SurGenTec, LLC | 0 |
| 2019-04-18 | VAI | Voluntary action indicated | SurGenTec, LLC | 3 |
| 2019-04-18 | VAI | Voluntary action indicated | SurGenTec, LLC | 3 |
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