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.
34 linked reportsMalfunction 32Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.61 |
| 2019-02 | 0 | 1.91 |
| 2019-03 | 0 | 1.82 |
| 2019-04 | 0 | 2.36 |
| 2019-05 | 0 | 1.75 |
| 2019-06 | 0 | 1.88 |
| 2019-07 | 0 | 2.51 |
| 2019-08 | 0 | 1.98 |
| 2019-09 | 0 | 1.7 |
| 2019-10 | 0 | 2.7 |
| 2019-11 | 0 | 1.95 |
| 2019-12 | 1 | 2.02 |
| 2020-01 | 0 | 2.84 |
| 2020-02 | 0 | 2.03 |
| 2020-03 | 0 | 2.19 |
| 2020-04 | 2 | 2.62 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.3 |
| 2020-07 | 0 | 3.16 |
| 2020-08 | 0 | 2.25 |
| 2020-09 | 0 | 2.27 |
| 2020-10 | 0 | 3.12 |
| 2020-11 | 0 | 2.26 |
| 2020-12 | 0 | 2.59 |
| 2021-01 | 1 | 2.54 |
| 2021-02 | 0 | 2.54 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 0 | 2.24 |
| 2021-05 | 0 | 2.74 |
| 2021-06 | 0 | 2.46 |
| 2021-07 | 0 | 2.21 |
| 2021-08 | 0 | 2.49 |
| 2021-09 | 1 | 2.25 |
| 2021-10 | 0 | 2.36 |
| 2021-11 | 1 | 2.08 |
| 2021-12 | 0 | 2.26 |
| 2022-01 | 0 | 2.18 |
| 2022-02 | 1 | 2.17 |
| 2022-03 | 0 | 1.97 |
| 2022-04 | 1 | 2.25 |
| 2022-05 | 0 | 1.86 |
| 2022-06 | 0 | 2.22 |
| 2022-07 | 0 | 2.06 |
| 2022-08 | 0 | 2.37 |
| 2022-09 | 0 | 2.18 |
| 2022-10 | 1 | 2.2 |
| 2022-11 | 1 | 2.06 |
| 2022-12 | 0 | 1.92 |
| 2023-01 | 1 | 1.8 |
| 2023-02 | 1 | 1.96 |
| 2023-03 | 0 | 2.01 |
| 2023-04 | 0 | 2.13 |
| 2023-05 | 0 | 1.85 |
| 2023-06 | 0 | 2.11 |
| 2023-07 | 0 | 2.05 |
| 2023-08 | 1 | 1.85 |
| 2023-09 | 0 | 1.92 |
| 2023-10 | 1 | 2.21 |
| 2023-11 | 0 | 2.39 |
| 2023-12 | 0 | 2.42 |
| 2024-01 | 0 | 1.77 |
| 2024-02 | 1 | 1.96 |
| 2024-03 | 0 | 1.83 |
| 2024-04 | 1 | 1.92 |
| 2024-05 | 0 | 1.94 |
| 2024-06 | 1 | 2.12 |
| 2024-07 | 1 | 1.99 |
| 2024-08 | 0 | 1.97 |
| 2024-09 | 0 | 2.07 |
| 2024-10 | 0 | 2.28 |
| 2024-11 | 0 | 2.41 |
| 2024-12 | 0 | 2.97 |
| 2025-01 | 1 | 2.91 |
| 2025-02 | 2 | 2.87 |
| 2025-03 | 0 | 2.68 |
| 2025-04 | 2 | 2.49 |
| 2025-05 | 1 | 2.66 |
| 2025-06 | 0 | 3.23 |
| 2025-07 | 1 | 3.2 |
| 2025-08 | 1 | 2.73 |
| 2025-09 | 0 | 2.88 |
| 2025-10 | 1 | 3.24 |
| 2025-11 | 0 | 3.19 |
| 2025-12 | 2 | 3.84 |
| 2026-01 | 3 | 3.49 |
| 2026-02 | 0 | 3.34 |
| 2026-03 | 0 | 3.29 |
| 2026-04 | 1 | 3.06 |
| 2026-05 | 1 | 3.41 |
| 2026-06 | 0 | 3.38 |
Failure-mode summaryAI-generated
34 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-20 | 2029214-2026-00931 | Malfunction | Available | exact di |
| 2026-04-15 | 2029214-2026-00680 | Malfunction | Available | exact di |
| 2026-01-29 | 2029214-2026-00182 | Malfunction | Available | exact di |
| 2026-01-28 | 2029214-2026-00174 | Malfunction | Available | exact di |
| 2026-01-13 | 2029214-2026-00068 | Injury | Available | exact di |
| 2025-12-17 | 2029214-2025-02653 | Malfunction | Available | exact di |
| 2025-12-10 | 2029214-2025-02602 | Malfunction | Available | exact di |
| 2025-10-22 | 2029214-2025-02260 | Malfunction | Available | exact di |
| 2025-08-15 | 2029214-2025-01826 | Malfunction | Available | exact di |
| 2025-07-21 | 2029214-2025-01651 | Malfunction | Available | exact di |
| 2025-05-30 | 2029214-2025-01274 | Malfunction | Available | exact di |
| 2025-04-23 | 2029214-2025-01054 | Malfunction | Available | exact di |
| 2025-04-03 | 2029214-2025-00872 | Malfunction | Available | exact di |
| 2025-02-13 | 2029214-2025-00414 | Malfunction | Available | exact di |
| 2025-02-06 | 2029214-2025-00317 | Malfunction | Available | exact di |
Showing 1–15 of 34
Regulatory clearances
Predicate lineage
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 |
|---|---|---|---|---|
| 2021-09-17 | VAI | Voluntary action indicated | Micro Therapeutics, Inc. | 0 |
| 2015-07-17 | VAI | Voluntary action indicated | Micro Therapeutics, Inc. | 1 |
| 2015-03-26 | NAI | No action indicated | Micro Therapeutics, Inc. | 0 |
| 2013-03-27 | NAI | No action indicated | Micro Therapeutics, Inc. | 0 |
| 2012-01-09 | NAI | No action indicated | Micro Therapeutics, Inc. | 0 |
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