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.
69 linked reportsMalfunction 55Injury 12Death 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.83 |
| 2019-02 | 0 | 3 |
| 2019-03 | 0 | 4 |
| 2019-04 | 0 | 2.5 |
| 2019-05 | 0 | 22 |
| 2019-06 | 0 | 4.25 |
| 2019-07 | 0 | 4.33 |
| 2019-08 | 0 | 7 |
| 2019-09 | 2 | 1.8 |
| 2019-10 | 0 | 1.6 |
| 2019-11 | 0 | 1.25 |
| 2019-12 | 0 | 2.33 |
| 2020-01 | 0 | 1.4 |
| 2020-02 | 0 | 2.38 |
| 2020-03 | 0 | 4 |
| 2020-04 | 0 | 1.67 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 2.5 |
| 2020-07 | 0 | 3 |
| 2020-08 | 0 | 4.33 |
| 2020-09 | 0 | 1.25 |
| 2020-10 | 0 | 6 |
| 2020-11 | 0 | 1.71 |
| 2020-12 | 0 | 3.67 |
| 2021-01 | 3 | 3 |
| 2021-02 | 0 | 3 |
| 2021-03 | 3 | 6 |
| 2021-04 | 0 | 5.33 |
| 2021-05 | 0 | 7.67 |
| 2021-06 | 0 | 5 |
| 2021-07 | 0 | 4.8 |
| 2021-08 | 3 | 3.64 |
| 2021-09 | 0 | 2.86 |
| 2021-10 | 0 | 3 |
| 2021-11 | 3 | 3 |
| 2021-12 | 3 | 2.83 |
| 2022-01 | 0 | 2.29 |
| 2022-02 | 0 | 3.5 |
| 2022-03 | 0 | 4.5 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 4.5 |
| 2022-06 | 3 | 2.91 |
| 2022-07 | 3 | 3.6 |
| 2022-08 | 0 | 2.67 |
| 2022-09 | 0 | 2.09 |
| 2022-10 | 0 | 3.25 |
| 2022-11 | 15 | 6.09 |
| 2022-12 | 0 | 1.56 |
| 2023-01 | 0 | 4.83 |
| 2023-02 | 3 | 2.7 |
| 2023-03 | 3 | 2.75 |
| 2023-04 | 3 | 3.44 |
| 2023-05 | 0 | 4.71 |
| 2023-06 | 0 | 3.27 |
| 2023-07 | 0 | 3.5 |
| 2023-08 | 0 | 3.33 |
| 2023-09 | 0 | 2.89 |
| 2023-10 | 0 | 2.5 |
| 2023-11 | 2 | 2.84 |
| 2023-12 | 2 | 3.9 |
| 2024-01 | 0 | 1.8 |
| 2024-02 | 0 | 2.73 |
| 2024-03 | 4 | 2.85 |
| 2024-04 | 2 | 3.77 |
| 2024-05 | 2 | 5.13 |
| 2024-06 | 2 | 2 |
| 2024-07 | 1 | 2.63 |
| 2024-08 | 0 | 6.67 |
| 2024-09 | 0 | 2.15 |
| 2024-10 | 0 | 3.85 |
| 2024-11 | 0 | 4.83 |
| 2024-12 | 0 | 3.86 |
| 2025-01 | 0 | 1.71 |
| 2025-02 | 4 | 4.05 |
| 2025-03 | 0 | 3.56 |
| 2025-04 | 0 | 2.07 |
| 2025-05 | 0 | 3.29 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 1.75 |
| 2025-08 | 0 | 4 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 2.17 |
| 2025-11 | 0 | 2.6 |
| 2025-12 | 0 | 1.83 |
| 2026-01 | 1 | 1.92 |
| 2026-02 | 2 | 2 |
| 2026-03 | 0 | 5 |
| 2026-04 | 0 | 1.36 |
| 2026-05 | 0 | 2.33 |
| 2026-06 | 0 | 1.67 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-12 | 3003418325-2026-00004 | Death | Available | catalog number |
| 2026-01-19 | 3003418325-2026-00002 | Malfunction | Available | catalog number |
| 2025-02-12 | 3005172759-2025-00014 | Injury | Available | catalog number |
| 2025-02-07 | 3005172759-2025-00004 | Malfunction | Available | catalog number |
| 2024-07-30 | 3005172759-2024-00079 | Injury | Available | catalog number |
| 2024-06-13 | 19528172 | Malfunction | Available | catalog number |
| 2024-05-06 | 3005172759-2024-00059 | Malfunction | Available | catalog number |
| 2024-04-25 | 3005172759-2024-00036 | Malfunction | Available | catalog number |
| 2024-03-22 | 3005172759-2024-00017 | Injury | Available | catalog number |
| 2024-03-22 | 3005172759-2024-00021 | Injury | Available | catalog number |
| 2023-12-14 | 3005172759-2023-00068 | Malfunction | Available | catalog number |
| 2023-11-03 | 3005172759-2023-00052 | Malfunction | Available | catalog number |
| 2023-04-05 | 3005172759-2023-00018 | Malfunction | Available | catalog number |
| 2023-03-10 | 3005172759-2023-00011 | Malfunction | Available | catalog number |
| 2023-02-27 | 3005172759-2023-00008 | Malfunction | Available | catalog number |
Showing the most recent 28 of 69 linked reports.
Showing 1–15 of 28
Regulatory clearances
- 510(k)K171687Substantially equivalent (SESE) · 2017-09-05clearance family
Predicate lineage
- K171687
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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