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.
3 linked reportsInjury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-04 | 0 | 2 |
| 2020-09 | 0 | 1 |
| 2021-08 | 0 | 3 |
| 2021-10 | 0 | 3 |
| 2022-03 | 0 | 6 |
| 2022-06 | 0 | 3 |
| 2022-10 | 1 | 1 |
| 2022-12 | 0 | 1 |
| 2023-03 | 0 | 1 |
| 2023-05 | 0 | 3 |
| 2023-06 | 0 | 6 |
| 2023-08 | 0 | 2 |
| 2024-01 | 0 | 2 |
| 2024-02 | 0 | 2 |
| 2024-04 | 0 | 2 |
| 2024-07 | 1 | 1 |
| 2024-08 | 0 | 2 |
| 2025-05 | 1 | 1 |
| 2025-06 | 0 | 1 |
| 2025-12 | 0 | 1 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-05-13 | 3005172759-2025-00033 | Injury | Available | catalog number |
| 2024-07-09 | 3005172759-2024-00074 | Injury | Available | catalog number |
| 2022-10-03 | 3005172759-2022-00023 | Injury | Available | catalog number |
Regulatory clearances
- De NovoDEN150056De Novo granted (DENG) · 2016-09-16 · +1 earlier decisionsclearance family
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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