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.
10 linked reportsMalfunction 10
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-05 | 0 | 2 |
| 2019-07 | 0 | 1 |
| 2019-12 | 1 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-06 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-11 | 1 | 1.5 |
| 2020-12 | 0 | 2 |
| 2021-05 | 0 | 1 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1.5 |
| 2021-09 | 0 | 1 |
| 2021-10 | 1 | 1 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-06 | 0 | 1.43 |
| 2022-08 | 1 | 1 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1 |
| 2023-01 | 0 | 1.4 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 1 |
| 2023-08 | 0 | 1.5 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 1.5 |
| 2023-12 | 0 | 2 |
| 2024-01 | 1 | 1 |
| 2024-03 | 0 | 1 |
| 2024-04 | 1 | 1.25 |
| 2024-05 | 0 | 1 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 1.5 |
| 2024-10 | 2 | 1.5 |
| 2024-11 | 0 | 3 |
| 2024-12 | 0 | 1.5 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 2 |
| 2025-06 | 0 | 1.5 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 1.5 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 1.25 |
| 2025-11 | 0 | 1 |
| 2025-12 | 2 | 2 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 1.29 |
Failure-mode summaryAI-generated
10 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-22 | 1518293-2025-00019 | Malfunction | Available | exact di |
| 2024-10-24 | 1518293-2024-00018 | Malfunction | Available | exact di |
| 2024-04-09 | 1518293-2024-00009 | Malfunction | Available | model number |
| 2024-01-03 | 1518293-2023-00042 | Malfunction | Available | model number |
| 2022-08-11 | 1518293-2022-00007 | Malfunction | Available | model number |
| 2021-10-19 | 1518293-2021-00036 | Malfunction | Available | model number |
| 2020-11-30 | 1518293-2020-00037 | Malfunction | Available | model number |
| 2019-12-02 | 1518293-2019-00024 | Malfunction | Available | model number |
Showing the most recent 8 of 10 linked reports.
Regulatory clearances
Predicate lineage
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 |
|---|---|---|---|---|
| 2018-03-15 | NAI | No action indicated | LIEBEL-FLARSHEIM COMPANY LLC | 0 |
| 2017-11-08 | VAI | Voluntary action indicated | Liebel-Flarsheim Company LLC | 4 |
| 2015-07-07 | NAI | No action indicated | Liebel-Flarsheim Company LLC | 0 |
| 2012-01-05 | VAI | Voluntary action indicated | Liebel-Flarsheim Company LLC | 0 |
| 2010-12-08 | VAI | Voluntary action indicated | Liebel-Flarsheim Company LLC | 0 |
| 2010-03-05 | NAI | No action indicated | Liebel-Flarsheim Company LLC | 0 |
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