Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European Union0724995ENBLOKLFSTRPT60724995ENBLOKLFSTRPT6
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.
9 linked reportsMalfunction 9
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-03 | 0 | 2 |
| 2019-05 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2019-09 | 0 | 2 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 2 |
| 2020-05 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-10 | 0 | 1.5 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 1 |
| 2021-06 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-03 | 1 | 1 |
| 2022-05 | 0 | 1 |
| 2022-07 | 0 | 4 |
| 2022-08 | 0 | 1 |
| 2023-04 | 0 | 1 |
| 2023-06 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2024-10 | 3 | 3 |
| 2025-01 | 0 | 1 |
| 2025-02 | 0 | 1 |
| 2025-03 | 2 | 2 |
| 2025-04 | 3 | 3 |
| 2025-05 | 0 | 1 |
| 2025-06 | 0 | 2 |
| 2025-07 | 0 | 1.5 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1.5 |
| 2026-05 | 0 | 1 |
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-04-03 | 1528319-2025-00026 | Malfunction | Available | catalog number |
| 2025-03-04 | 21513837 | Malfunction | Available | catalog number |
| 2024-10-17 | 1528319-2024-00089 | Malfunction | Available | catalog number |
| 2022-03-25 | 1528319-2022-00015 | Malfunction | Available | exact di |
Showing the most recent 4 of 9 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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