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.
1,656 linked reportsMalfunction 1,654Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 39 | 13.41 |
| 2019-02 | 17 | 3.29 |
| 2019-03 | 17 | 3.78 |
| 2019-04 | 28 | 4.27 |
| 2019-05 | 36 | 4.18 |
| 2019-06 | 50 | 3.67 |
| 2019-07 | 30 | 3.38 |
| 2019-08 | 28 | 3.9 |
| 2019-09 | 19 | 4.55 |
| 2019-10 | 24 | 5.02 |
| 2019-11 | 17 | 4.63 |
| 2019-12 | 32 | 5.21 |
| 2020-01 | 21 | 5.18 |
| 2020-02 | 11 | 5.84 |
| 2020-03 | 29 | 5.61 |
| 2020-04 | 29 | 5 |
| 2020-05 | 13 | 3.51 |
| 2020-06 | 16 | 5.69 |
| 2020-07 | 23 | 6.15 |
| 2020-08 | 32 | 5.71 |
| 2020-09 | 40 | 7.49 |
| 2020-10 | 36 | 8.72 |
| 2020-11 | 25 | 5.95 |
| 2020-12 | 42 | 8.86 |
| 2021-01 | 41 | 6.31 |
| 2021-02 | 27 | 5.77 |
| 2021-03 | 35 | 7.8 |
| 2021-04 | 35 | 6.1 |
| 2021-05 | 19 | 5.63 |
| 2021-06 | 35 | 5.7 |
| 2021-07 | 33 | 4.96 |
| 2021-08 | 23 | 5.25 |
| 2021-09 | 11 | 3.47 |
| 2021-10 | 21 | 5.1 |
| 2021-11 | 29 | 3.78 |
| 2021-12 | 31 | 5.41 |
| 2022-01 | 24 | 4.97 |
| 2022-02 | 14 | 3.74 |
| 2022-03 | 33 | 4.39 |
| 2022-04 | 14 | 4.17 |
| 2022-05 | 15 | 4.13 |
| 2022-06 | 20 | 4.35 |
| 2022-07 | 20 | 4.38 |
| 2022-08 | 28 | 4.33 |
| 2022-09 | 12 | 4.16 |
| 2022-10 | 10 | 4.1 |
| 2022-11 | 30 | 4.7 |
| 2022-12 | 21 | 4.67 |
| 2023-01 | 25 | 5.09 |
| 2023-02 | 16 | 4.36 |
| 2023-03 | 33 | 5.24 |
| 2023-04 | 24 | 4.82 |
| 2023-05 | 29 | 4.84 |
| 2023-06 | 17 | 4.5 |
| 2023-07 | 18 | 4.29 |
| 2023-08 | 15 | 5.05 |
| 2023-09 | 11 | 4.83 |
| 2023-10 | 8 | 4.41 |
| 2023-11 | 13 | 7.93 |
| 2023-12 | 8 | 8.8 |
| 2024-01 | 13 | 6.2 |
| 2024-02 | 7 | 6.57 |
| 2024-03 | 9 | 5.26 |
| 2024-04 | 6 | 5.97 |
| 2024-05 | 9 | 8.82 |
| 2024-06 | 7 | 8.82 |
| 2024-07 | 10 | 4.91 |
| 2024-08 | 7 | 4.86 |
| 2024-09 | 6 | 4.76 |
| 2024-10 | 11 | 6.15 |
| 2024-11 | 8 | 5.22 |
| 2024-12 | 8 | 7.58 |
| 2025-01 | 13 | 8.91 |
| 2025-02 | 2 | 6.11 |
| 2025-03 | 3 | 5.08 |
| 2025-04 | 6 | 5.43 |
| 2025-05 | 7 | 5.98 |
| 2025-06 | 2 | 5.09 |
| 2025-07 | 9 | 5.28 |
| 2025-08 | 6 | 4.37 |
| 2025-09 | 6 | 4.58 |
| 2025-10 | 3 | 5.09 |
| 2025-11 | 4 | 5.68 |
| 2025-12 | 13 | 5.94 |
| 2026-01 | 10 | 5.53 |
| 2026-02 | 1 | 5.56 |
| 2026-03 | 3 | 5.59 |
| 2026-04 | 9 | 7 |
| 2026-05 | 1 | 4.7 |
| 2026-06 | 5 | 4.85 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2015-11-20 | Z-0656-2016 | Class II | Terminated | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.Distribution: Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ. | 50 units | clearance family |
| 2015-11-20 | Z-0657-2016 | Class II | Terminated | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.Distribution: Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ. | 45 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-26 | 1221934-2026-02804 | Malfunction | Available | exact di |
| 2026-06-19 | 1221934-2026-02699 | Malfunction | Available | exact di |
| 2026-06-16 | 1221934-2026-02616 | Malfunction | Available | exact di |
| 2026-06-02 | 1221934-2026-02366 | Malfunction | Available | exact di |
| 2026-06-02 | 1221934-2026-02365 | Malfunction | Available | exact di |
| 2026-05-12 | 1221934-2026-02006 | Malfunction | Available | exact di |
| 2026-04-30 | 1221934-2026-01804 | Malfunction | Available | exact di |
| 2026-04-24 | 1221934-2026-01658 | Malfunction | Available | exact di |
| 2026-04-23 | 1221934-2026-01644 | Malfunction | Available | exact di |
| 2026-04-21 | 1221934-2026-01579 | Malfunction | Available | exact di |
| 2026-04-21 | 1221934-2026-01582 | Malfunction | Available | exact di |
| 2026-04-16 | 1221934-2026-01511 | Malfunction | Available | exact di |
| 2026-04-10 | 1221934-2026-01475 | Malfunction | Available | exact di |
| 2026-04-06 | 1221934-2026-01404 | Malfunction | Available | exact di |
| 2026-04-01 | 1221934-2026-01331 | Malfunction | Available | exact di |
Showing the most recent 200 of 1,656 linked reports.
Showing 1–15 of 200
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
None in the loaded window.
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