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.
12 linked reportsMalfunction 11Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.64 |
| 2019-02 | 0 | 1.52 |
| 2019-03 | 0 | 1.76 |
| 2019-04 | 0 | 1.69 |
| 2019-05 | 0 | 1.69 |
| 2019-06 | 0 | 1.55 |
| 2019-07 | 0 | 2.02 |
| 2019-08 | 0 | 2.38 |
| 2019-09 | 0 | 2.08 |
| 2019-10 | 0 | 2.24 |
| 2019-11 | 0 | 2.03 |
| 2019-12 | 0 | 2.52 |
| 2020-01 | 0 | 2.27 |
| 2020-02 | 0 | 2.9 |
| 2020-03 | 0 | 2.85 |
| 2020-04 | 0 | 2.16 |
| 2020-05 | 0 | 2.68 |
| 2020-06 | 0 | 2.46 |
| 2020-07 | 0 | 2.83 |
| 2020-08 | 0 | 2.54 |
| 2020-09 | 0 | 2.39 |
| 2020-10 | 0 | 2.62 |
| 2020-11 | 1 | 2.65 |
| 2020-12 | 0 | 2.71 |
| 2021-01 | 0 | 3 |
| 2021-02 | 0 | 2.12 |
| 2021-03 | 0 | 2.65 |
| 2021-04 | 0 | 2.6 |
| 2021-05 | 0 | 2.02 |
| 2021-06 | 0 | 2.4 |
| 2021-07 | 2 | 2.95 |
| 2021-08 | 1 | 2.36 |
| 2021-09 | 1 | 2.32 |
| 2021-10 | 0 | 1.97 |
| 2021-11 | 0 | 2.33 |
| 2021-12 | 0 | 2.59 |
| 2022-01 | 0 | 2.58 |
| 2022-02 | 0 | 2.37 |
| 2022-03 | 0 | 2.41 |
| 2022-04 | 0 | 2.51 |
| 2022-05 | 1 | 2.78 |
| 2022-06 | 0 | 2.69 |
| 2022-07 | 0 | 2.47 |
| 2022-08 | 2 | 2.92 |
| 2022-09 | 0 | 2.5 |
| 2022-10 | 0 | 2.18 |
| 2022-11 | 0 | 2.58 |
| 2022-12 | 0 | 2.33 |
| 2023-01 | 0 | 1.86 |
| 2023-02 | 0 | 2.53 |
| 2023-03 | 1 | 2.51 |
| 2023-04 | 0 | 2.18 |
| 2023-05 | 0 | 2.87 |
| 2023-06 | 0 | 2.34 |
| 2023-07 | 0 | 2.57 |
| 2023-08 | 0 | 2.62 |
| 2023-09 | 0 | 2.63 |
| 2023-10 | 0 | 2.51 |
| 2023-11 | 0 | 2.55 |
| 2023-12 | 0 | 2.68 |
| 2024-01 | 0 | 2.57 |
| 2024-02 | 0 | 2.6 |
| 2024-03 | 0 | 2.76 |
| 2024-04 | 0 | 2.2 |
| 2024-05 | 0 | 3.17 |
| 2024-06 | 0 | 2.94 |
| 2024-07 | 0 | 2.24 |
| 2024-08 | 0 | 3.44 |
| 2024-09 | 0 | 2.96 |
| 2024-10 | 1 | 3.8 |
| 2024-11 | 0 | 3.29 |
| 2024-12 | 0 | 3.67 |
| 2025-01 | 0 | 2.94 |
| 2025-02 | 0 | 3.07 |
| 2025-03 | 0 | 3.1 |
| 2025-04 | 0 | 3.32 |
| 2025-05 | 1 | 3.15 |
| 2025-06 | 0 | 2.88 |
| 2025-07 | 0 | 2.97 |
| 2025-08 | 1 | 3.12 |
| 2025-09 | 0 | 3.33 |
| 2025-10 | 0 | 3.11 |
| 2025-11 | 0 | 3.84 |
| 2025-12 | 0 | 4.14 |
| 2026-01 | 0 | 3.52 |
| 2026-02 | 0 | 3.82 |
| 2026-03 | 0 | 3.83 |
| 2026-04 | 0 | 2.94 |
| 2026-05 | 0 | 2.6 |
| 2026-06 | 0 | 2.77 |
Failure-mode summaryAI-generated
12 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-13 | 2029214-2025-01821 | Malfunction | Available | exact di |
| 2025-05-01 | 2029214-2025-01113 | Malfunction | Available | exact di |
| 2024-10-14 | 2029214-2024-01870 | Malfunction | Available | exact di |
| 2023-03-07 | 2029214-2023-00418 | Injury | Available | exact di |
| 2022-08-30 | 2029214-2022-01464 | Malfunction | Available | exact di |
| 2022-08-23 | 2029214-2022-01427 | Malfunction | Available | exact di |
| 2022-05-09 | 2029214-2022-00803 | Malfunction | Available | exact di |
| 2021-09-29 | 2029214-2021-01217 | Malfunction | Available | exact di |
| 2021-08-02 | 2029214-2021-00966 | Malfunction | Available | exact di |
| 2021-07-27 | 2029214-2021-00925 | Malfunction | Available | exact di |
| 2021-07-01 | 2029214-2021-00801 | Malfunction | Available | exact di |
| 2020-11-25 | 2029214-2020-01183 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K201690Substantially equivalent (SESE) · 2020-07-21clearance family
- 510(k)K193548Substantially equivalent (SESE) · 2020-01-18clearance family
Predicate lineage
- K193548
Cited as predicate by: K201690
- K201690
Cited as predicate by: K252011
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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