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.
246 linked reportsMalfunction 160Injury 86
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 15.5 |
| 2019-03 | 0 | 29 |
| 2019-04 | 0 | 15 |
| 2019-05 | 0 | 11.67 |
| 2019-06 | 0 | 14.33 |
| 2019-07 | 2 | 10.33 |
| 2019-08 | 0 | 15.67 |
| 2019-09 | 0 | 8.2 |
| 2019-10 | 0 | 15.33 |
| 2019-11 | 0 | 14.67 |
| 2019-12 | 0 | 13.25 |
| 2020-01 | 0 | 22 |
| 2020-02 | 0 | 20 |
| 2020-03 | 0 | 20.5 |
| 2020-04 | 0 | 34 |
| 2020-05 | 0 | 6 |
| 2020-06 | 1 | 6.7 |
| 2020-07 | 1 | 7.57 |
| 2020-08 | 0 | 8.33 |
| 2020-09 | 0 | 10.4 |
| 2020-10 | 0 | 6.55 |
| 2020-11 | 0 | 10.33 |
| 2020-12 | 0 | 8.71 |
| 2021-01 | 0 | 6.67 |
| 2021-02 | 0 | 5.71 |
| 2021-03 | 0 | 7.4 |
| 2021-04 | 0 | 9.17 |
| 2021-05 | 2 | 7.67 |
| 2021-06 | 0 | 6.78 |
| 2021-07 | 2 | 6.2 |
| 2021-08 | 0 | 10.4 |
| 2021-09 | 1 | 11.8 |
| 2021-10 | 0 | 9.75 |
| 2021-11 | 2 | 5.5 |
| 2021-12 | 2 | 8.25 |
| 2022-01 | 0 | 15.5 |
| 2022-02 | 3 | 4.36 |
| 2022-03 | 7 | 8.14 |
| 2022-04 | 0 | 7.4 |
| 2022-05 | 10 | 6 |
| 2022-06 | 7 | 10.17 |
| 2022-07 | 9 | 14 |
| 2022-08 | 3 | 6.63 |
| 2022-09 | 5 | 14 |
| 2022-10 | 5 | 9.33 |
| 2022-11 | 5 | 8.17 |
| 2022-12 | 2 | 11.75 |
| 2023-01 | 3 | 10 |
| 2023-02 | 2 | 8.2 |
| 2023-03 | 4 | 8.25 |
| 2023-04 | 4 | 9 |
| 2023-05 | 6 | 10.75 |
| 2023-06 | 12 | 11.2 |
| 2023-07 | 5 | 9.67 |
| 2023-08 | 7 | 6.67 |
| 2023-09 | 1 | 6.4 |
| 2023-10 | 4 | 7.25 |
| 2023-11 | 3 | 14 |
| 2023-12 | 3 | 6.25 |
| 2024-01 | 15 | 14.75 |
| 2024-02 | 14 | 5.6 |
| 2024-03 | 10 | 7.75 |
| 2024-04 | 9 | 5.2 |
| 2024-05 | 7 | 3.6 |
| 2024-06 | 14 | 7 |
| 2024-07 | 4 | 5.17 |
| 2024-08 | 5 | 5 |
| 2024-09 | 6 | 8 |
| 2024-10 | 5 | 7.33 |
| 2024-11 | 4 | 3.8 |
| 2024-12 | 2 | 4.83 |
| 2025-01 | 2 | 5.4 |
| 2025-02 | 1 | 3 |
| 2025-03 | 1 | 4.2 |
| 2025-04 | 2 | 3.83 |
| 2025-05 | 1 | 2.6 |
| 2025-06 | 2 | 4.33 |
| 2025-07 | 3 | 6.25 |
| 2025-08 | 3 | 5.33 |
| 2025-09 | 3 | 3 |
| 2025-10 | 4 | 3.2 |
| 2025-11 | 0 | 3.43 |
| 2025-12 | 0 | 3 |
| 2026-01 | 2 | 3 |
| 2026-02 | 2 | 2.75 |
| 2026-03 | 2 | 2.6 |
| 2026-04 | 0 | 6 |
| 2026-05 | 0 | 3.33 |
| 2026-06 | 0 | 3 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-04-11 | Z-1716-2025 | Class I | Open, Classified | Inadequate weld that can potentially cause the product to disassemble.Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom. | 170,510 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-17 | 3014334038-2026-00026 | Injury | Available | exact di |
| 2026-03-13 | 3014334038-2026-00024 | Malfunction | Available | exact di |
| 2026-02-20 | 3014334038-2026-00015 | Injury | Available | exact di |
| 2026-02-13 | 3014334038-2026-00007 | Malfunction | Available | exact di |
| 2026-01-21 | 3014334038-2026-00003 | Injury | Available | exact di |
| 2026-01-21 | 3014334038-2026-00004 | Malfunction | Available | exact di |
| 2025-10-24 | 3014334038-2025-00139 | Malfunction | Available | exact di |
| 2025-10-17 | 3014334038-2025-00136 | Malfunction | Available | exact di |
| 2025-10-10 | 3014334038-2025-00135 | Malfunction | Available | exact di |
| 2025-10-09 | 3014334038-2025-00138 | Malfunction | Available | exact di |
| 2025-09-05 | 3014334038-2025-00124 | Malfunction | Available | exact di |
| 2025-09-05 | 3014334038-2025-00123 | Malfunction | Available | exact di |
| 2025-09-05 | 3014334038-2025-00122 | Malfunction | Available | exact di |
| 2025-08-28 | 3014334038-2025-00117 | Injury | Available | exact di |
| 2025-08-28 | 3014334038-2025-00120 | Malfunction | Available | exact di |
Showing the most recent 200 of 246 linked reports.
Showing 1–15 of 200
Regulatory clearances
Predicate lineage
K791101
Cited as predicate by: K183581
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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