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.
8 linked reportsInjury 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.77 |
| 2019-02 | 0 | 2.43 |
| 2019-03 | 1 | 2.68 |
| 2019-04 | 0 | 2.56 |
| 2019-05 | 0 | 2.07 |
| 2019-06 | 0 | 1.79 |
| 2019-07 | 0 | 1.79 |
| 2019-08 | 0 | 2.06 |
| 2019-09 | 0 | 2.19 |
| 2019-10 | 0 | 2.37 |
| 2019-11 | 0 | 2 |
| 2019-12 | 0 | 2.31 |
| 2020-01 | 0 | 2.62 |
| 2020-02 | 0 | 2.38 |
| 2020-03 | 0 | 2.94 |
| 2020-04 | 0 | 2.15 |
| 2020-05 | 0 | 2.15 |
| 2020-06 | 0 | 1.98 |
| 2020-07 | 0 | 2.35 |
| 2020-08 | 0 | 1.93 |
| 2020-09 | 0 | 2.37 |
| 2020-10 | 0 | 2.41 |
| 2020-11 | 0 | 2.18 |
| 2020-12 | 0 | 2.17 |
| 2021-01 | 0 | 2.28 |
| 2021-02 | 0 | 1.94 |
| 2021-03 | 1 | 1.96 |
| 2021-04 | 0 | 1.96 |
| 2021-05 | 0 | 1.93 |
| 2021-06 | 1 | 2.28 |
| 2021-07 | 0 | 2.22 |
| 2021-08 | 0 | 2.18 |
| 2021-09 | 0 | 2.28 |
| 2021-10 | 0 | 2.11 |
| 2021-11 | 0 | 2.05 |
| 2021-12 | 0 | 2.21 |
| 2022-01 | 0 | 2.03 |
| 2022-02 | 0 | 2.14 |
| 2022-03 | 0 | 2.03 |
| 2022-04 | 0 | 2.1 |
| 2022-05 | 0 | 2.04 |
| 2022-06 | 1 | 2.15 |
| 2022-07 | 0 | 2.01 |
| 2022-08 | 0 | 2.09 |
| 2022-09 | 0 | 2.06 |
| 2022-10 | 0 | 2.02 |
| 2022-11 | 0 | 2.16 |
| 2022-12 | 0 | 2.06 |
| 2023-01 | 0 | 2.09 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 2.16 |
| 2023-04 | 0 | 2.11 |
| 2023-05 | 0 | 2.07 |
| 2023-06 | 0 | 2.17 |
| 2023-07 | 0 | 2.04 |
| 2023-08 | 0 | 1.89 |
| 2023-09 | 0 | 1.85 |
| 2023-10 | 0 | 1.59 |
| 2023-11 | 0 | 1.58 |
| 2023-12 | 0 | 1.6 |
| 2024-01 | 0 | 1.73 |
| 2024-02 | 0 | 1.95 |
| 2024-03 | 0 | 1.83 |
| 2024-04 | 1 | 1.71 |
| 2024-05 | 0 | 1.96 |
| 2024-06 | 0 | 1.85 |
| 2024-07 | 0 | 1.66 |
| 2024-08 | 0 | 1.79 |
| 2024-09 | 0 | 1.96 |
| 2024-10 | 0 | 1.72 |
| 2024-11 | 0 | 1.67 |
| 2024-12 | 1 | 1.56 |
| 2025-01 | 0 | 1.81 |
| 2025-02 | 0 | 1.52 |
| 2025-03 | 0 | 1.77 |
| 2025-04 | 1 | 1.77 |
| 2025-05 | 0 | 1.71 |
| 2025-06 | 1 | 1.8 |
| 2025-07 | 0 | 1.75 |
| 2025-08 | 0 | 1.66 |
| 2025-09 | 0 | 1.65 |
| 2025-10 | 0 | 1.67 |
| 2025-11 | 0 | 1.77 |
| 2025-12 | 0 | 1.93 |
| 2026-01 | 0 | 1.93 |
| 2026-02 | 0 | 1.64 |
| 2026-03 | 0 | 1.87 |
| 2026-04 | 0 | 1.81 |
| 2026-05 | 0 | 1.68 |
| 2026-06 | 0 | 1.67 |
Failure-mode summaryAI-generated
8 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2019-08-21 | Z-0519-2020 | Class II | Terminated | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.Distribution: US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela. | 219988 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-06-11 | 0001825034-2025-01686 | Injury | Available | exact di |
| 2025-04-24 | 0001825034-2025-01206 | Injury | Available | exact di |
| 2024-12-30 | 0001825034-2024-03071 | Injury | Available | exact di |
| 2024-04-12 | 0001825034-2024-01013 | Injury | Available | exact di |
| 2022-06-02 | 0001825034-2022-01282 | Injury | Available | exact di |
| 2021-06-30 | 0001825034-2021-01938 | Injury | Available | exact di |
| 2021-03-31 | 0001825034-2021-00948 | Injury | Available | exact di |
| 2019-03-22 | 0001825034-2019-01346 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
K043547
Cited as predicate by: K101475
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
None in the loaded window.
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