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) |
|---|---|---|
| 2020-12 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2022-09 | 0 | 2 |
| 2023-02 | 1 | 1 |
| 2023-03 | 0 | 3 |
| 2023-08 | 0 | 2 |
| 2024-02 | 0 | 2 |
| 2025-07 | 0 | 2 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 3 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 2 |
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 |
|---|---|---|---|---|
| 2023-02-06 | 8030673-2023-00296 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-04-08 | NAI | No action indicated | Vyaire Medical, Inc. | 0 |
| 2017-05-05 | NAI | No action indicated | Vyaire Medical, Inc. | 0 |
| 2016-05-11 | NAI | No action indicated | Vyaire Medical, Inc. | 0 |
| 2014-10-31 | VAI | Voluntary action indicated | Vyaire Medical, Inc. | 4 |
| 2014-10-08 | NAI | No action indicated | Vyaire Medical Inc | 0 |
| 2014-09-30 | NAI | No action indicated | Vyaire Medical | 0 |
| 2012-09-05 | VAI | Voluntary action indicated | Vyaire Medical | 5 |
| 2012-01-10 | NAI | No action indicated | Vyaire Medical | 0 |
| 2012-01-10 | NAI | No action indicated | Vyaire Medical | 0 |
| 2011-11-25 | NAI | No action indicated | Vyaire Medical | 0 |
| 2011-08-22 | NAI | No action indicated | Vyaire Medical, Inc. | 0 |
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