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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 1.25 |
| 2019-05 | 0 | 1.2 |
| 2019-08 | 0 | 1.5 |
| 2019-09 | 0 | 1.5 |
| 2019-10 | 0 | 1.5 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1.4 |
| 2020-07 | 0 | 2 |
| 2020-08 | 0 | 1 |
| 2021-08 | 0 | 2 |
| 2022-01 | 0 | 1.5 |
| 2022-02 | 0 | 1 |
| 2022-03 | 1 | 1.5 |
| 2022-06 | 0 | 1.67 |
| 2022-07 | 0 | 1.5 |
| 2022-10 | 0 | 3 |
| 2023-01 | 0 | 2 |
| 2023-03 | 0 | 1 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1 |
| 2023-08 | 0 | 1.5 |
| 2024-06 | 0 | 1.33 |
| 2024-07 | 0 | 2.25 |
| 2024-09 | 0 | 1 |
| 2024-10 | 0 | 2 |
| 2025-03 | 0 | 2.5 |
| 2025-06 | 0 | 1 |
| 2025-08 | 0 | 1.5 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-03-16 | 1045254-2022-00140 | Malfunction | Available | model number |
Regulatory clearances
Predicate lineage
K002897
Cited as predicate by: K130512
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 |
|---|---|---|---|---|
| 2024-06-17 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 1 |
| 2021-10-29 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 5 |
| 2015-09-21 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 1 |
| 2012-07-03 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 8 |
| 2012-06-06 | NAI | No action indicated | Medtronic Xomed, Inc. | 0 |
| 2010-08-05 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 4 |
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