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) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-10 | 0 | 2 |
| 2020-02 | 0 | 1 |
| 2020-04 | 0 | 3 |
| 2021-01 | 0 | 2 |
| 2021-03 | 0 | 3 |
| 2021-05 | 0 | 1 |
| 2021-06 | 0 | 1 |
| 2021-09 | 0 | 1.33 |
| 2021-12 | 0 | 3 |
| 2022-03 | 0 | 3 |
| 2022-04 | 0 | 3 |
| 2022-10 | 1 | 2 |
| 2022-11 | 0 | 2 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 2 |
| 2023-08 | 0 | 2 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 2 |
| 2023-12 | 0 | 2 |
| 2024-01 | 0 | 1 |
| 2024-06 | 0 | 1 |
| 2024-11 | 0 | 1 |
| 2025-01 | 0 | 1 |
| 2025-02 | 0 | 2.33 |
| 2025-04 | 0 | 4 |
| 2025-11 | 0 | 1.8 |
| 2025-12 | 0 | 3.67 |
| 2026-03 | 0 | 2 |
| 2026-06 | 0 | 1 |
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 |
|---|---|---|---|---|
| 2022-10-20 | 3009051471-2018-00017 | Malfunction | Available | model number |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-05-01 | NAI | No action indicated | CTL Medical Corporation | 0 |
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