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.
35 linked reportsMalfunction 29Injury 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.1 |
| 2019-02 | 0 | 3.57 |
| 2019-03 | 0 | 6.2 |
| 2019-04 | 0 | 5.17 |
| 2019-05 | 0 | 4.16 |
| 2019-06 | 0 | 4.14 |
| 2019-07 | 0 | 4.22 |
| 2019-08 | 0 | 5.34 |
| 2019-09 | 0 | 4.06 |
| 2019-10 | 0 | 4.11 |
| 2019-11 | 0 | 5.05 |
| 2019-12 | 0 | 5.06 |
| 2020-01 | 0 | 4.14 |
| 2020-02 | 0 | 3.82 |
| 2020-03 | 0 | 4.81 |
| 2020-04 | 0 | 4.42 |
| 2020-05 | 0 | 2.97 |
| 2020-06 | 0 | 5.43 |
| 2020-07 | 0 | 5.29 |
| 2020-08 | 0 | 4.58 |
| 2020-09 | 0 | 4.32 |
| 2020-10 | 0 | 5.16 |
| 2020-11 | 0 | 4.65 |
| 2020-12 | 0 | 5.08 |
| 2021-01 | 0 | 4.75 |
| 2021-02 | 0 | 5.08 |
| 2021-03 | 0 | 5.81 |
| 2021-04 | 0 | 4.61 |
| 2021-05 | 0 | 4.72 |
| 2021-06 | 0 | 5.4 |
| 2021-07 | 0 | 4.56 |
| 2021-08 | 0 | 4.92 |
| 2021-09 | 0 | 3.87 |
| 2021-10 | 0 | 3.18 |
| 2021-11 | 0 | 4.04 |
| 2021-12 | 0 | 3.67 |
| 2022-01 | 0 | 3.4 |
| 2022-02 | 0 | 3.18 |
| 2022-03 | 0 | 3.43 |
| 2022-04 | 0 | 3.71 |
| 2022-05 | 0 | 3.01 |
| 2022-06 | 0 | 4.01 |
| 2022-07 | 0 | 4.15 |
| 2022-08 | 0 | 4.22 |
| 2022-09 | 0 | 3.56 |
| 2022-10 | 0 | 4.17 |
| 2022-11 | 0 | 4.43 |
| 2022-12 | 0 | 4.13 |
| 2023-01 | 0 | 3.53 |
| 2023-02 | 0 | 3.79 |
| 2023-03 | 0 | 4.43 |
| 2023-04 | 3 | 3.95 |
| 2023-05 | 0 | 5.04 |
| 2023-06 | 3 | 3.88 |
| 2023-07 | 0 | 4.26 |
| 2023-08 | 0 | 3.73 |
| 2023-09 | 0 | 3.74 |
| 2023-10 | 2 | 3.48 |
| 2023-11 | 4 | 3.65 |
| 2023-12 | 4 | 3.43 |
| 2024-01 | 0 | 3.84 |
| 2024-02 | 0 | 4.49 |
| 2024-03 | 2 | 4.1 |
| 2024-04 | 0 | 4.23 |
| 2024-05 | 4 | 3.21 |
| 2024-06 | 2 | 3.29 |
| 2024-07 | 3 | 3.49 |
| 2024-08 | 0 | 3.73 |
| 2024-09 | 0 | 4.31 |
| 2024-10 | 0 | 4.09 |
| 2024-11 | 0 | 3.75 |
| 2024-12 | 0 | 3.48 |
| 2025-01 | 0 | 2.79 |
| 2025-02 | 4 | 6.44 |
| 2025-03 | 0 | 4.81 |
| 2025-04 | 2 | 2.87 |
| 2025-05 | 0 | 4.48 |
| 2025-06 | 0 | 3.71 |
| 2025-07 | 0 | 3.62 |
| 2025-08 | 0 | 3.52 |
| 2025-09 | 2 | 3.1 |
| 2025-10 | 0 | 3.67 |
| 2025-11 | 0 | 3.3 |
| 2025-12 | 0 | 3.28 |
| 2026-01 | 0 | 2.53 |
| 2026-02 | 0 | 3.33 |
| 2026-03 | 0 | 3.73 |
| 2026-04 | 0 | 4.7 |
| 2026-05 | 0 | 3.91 |
| 2026-06 | 0 | 4 |
Failure-mode summaryAI-generated
35 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-09-11 | 3003418325-2025-00054 | Malfunction | Available | catalog number |
| 2025-04-30 | 3005172759-2025-00031 | Malfunction | Available | catalog number |
| 2025-02-24 | 3005172759-2025-00018 | Malfunction | Available | catalog number |
| 2025-02-07 | 3005172759-2025-00005 | Malfunction | Available | catalog number |
| 2024-07-30 | 3005172759-2024-00078 | Injury | Available | catalog number |
| 2024-07-02 | 3005172759-2024-00073 | Malfunction | Available | catalog number |
| 2024-06-05 | 3005172759-2024-00068 | Malfunction | Available | catalog number |
| 2024-05-22 | 3005172759-2024-00063 | Malfunction | Available | catalog number |
| 2024-05-06 | 3005172759-2024-00058 | Malfunction | Available | catalog number |
| 2024-03-05 | 3005172759-2024-00014 | Malfunction | Available | catalog number |
| 2023-12-04 | 3005172759-2023-00066 | Injury | Available | catalog number |
| 2023-12-04 | 3005172759-2023-00063 | Malfunction | Available | catalog number |
| 2023-11-06 | 3005172759-2023-00062 | Malfunction | Available | catalog number |
| 2023-11-01 | 3005172759-2023-00053 | Malfunction | Available | catalog number |
| 2023-10-18 | 3005172759-2023-00047 | Malfunction | Available | catalog number |
Showing the most recent 17 of 35 linked reports.
Showing 1–15 of 17
Regulatory clearances
- 510(k)K221037Substantially equivalent (SESE) · 2022-07-20clearance family
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 |
|---|---|---|---|---|
| 2020-09-25 | NAI | No action indicated | Acclarent, Inc. | 0 |
| 2020-09-25 | NAI | No action indicated | Acclarent, Inc. | 0 |
| 2013-12-09 | VAI | Voluntary action indicated | Acclarent, Inc. | 0 |
| 2013-12-09 | VAI | Voluntary action indicated | Acclarent, Inc. | 0 |
| 2013-03-20 | WL | Warning Letter | Acclarent, Inc. | — |
| 2013-03-20 | WL | Warning Letter | Acclarent, Inc. | — |
| 2013-02-22 | OAI | Official action indicated | Acclarent, Inc. | 2 |
| 2013-02-22 | OAI | Official action indicated | Acclarent, Inc. | 2 |
| 2012-06-14 | WL | Warning Letter | Acclarent, Inc. | — |
| 2012-06-14 | WL | Warning Letter | Acclarent, Inc. | — |
| 2012-02-24 | OAI | Official action indicated | Acclarent, Inc. | 3 |
| 2012-02-24 | OAI | Official action indicated | Acclarent, Inc. | 3 |
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