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.
17 linked reportsInjury 9Malfunction 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2020-09 | 3 | 3 |
| 2021-09 | 0 | 3 |
| 2022-06 | 3 | 3 |
| 2024-03 | 5 | 5 |
| 2024-04 | 1 | 1 |
| 2024-06 | 3 | 3 |
| 2024-09 | 2 | 2 |
Failure-mode summaryAI-generated
17 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-09-04 | 3005172759-2024-00086 | Malfunction | Available | catalog number |
| 2024-06-06 | 19475871 | Malfunction | Available | catalog number |
| 2024-04-15 | 3005172759-2024-00028 | Injury | Available | exact di |
| 2024-03-22 | 3005172759-2024-00016 | Injury | Available | catalog number |
| 2024-03-06 | 18844977 | Malfunction | Available | catalog number |
| 2022-06-27 | 3005172759-2022-00014 | Injury | Available | catalog number |
| 2020-09-14 | 3005172759-2020-00004 | Injury | Available | catalog number |
Showing the most recent 7 of 17 linked reports.
Regulatory clearances
- 510(k)K183090Substantially equivalent (SESE) · 2019-04-19clearance family
Predicate lineage
K183090
Cited as predicate by: K181546
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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