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.
3 linked reportsInjury 3
| 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 | 0 | 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 | 0 | 6.7 |
| 2020-07 | 0 | 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 | 0 | 7.67 |
| 2021-06 | 0 | 6.78 |
| 2021-07 | 0 | 6.2 |
| 2021-08 | 0 | 10.4 |
| 2021-09 | 0 | 11.8 |
| 2021-10 | 0 | 9.75 |
| 2021-11 | 0 | 5.5 |
| 2021-12 | 0 | 8.25 |
| 2022-01 | 0 | 15.5 |
| 2022-02 | 0 | 4.36 |
| 2022-03 | 0 | 8.14 |
| 2022-04 | 0 | 7.4 |
| 2022-05 | 0 | 6 |
| 2022-06 | 0 | 10.17 |
| 2022-07 | 0 | 14 |
| 2022-08 | 1 | 6.63 |
| 2022-09 | 0 | 14 |
| 2022-10 | 0 | 9.33 |
| 2022-11 | 0 | 8.17 |
| 2022-12 | 1 | 11.75 |
| 2023-01 | 0 | 10 |
| 2023-02 | 0 | 8.2 |
| 2023-03 | 0 | 8.25 |
| 2023-04 | 0 | 9 |
| 2023-05 | 0 | 10.75 |
| 2023-06 | 1 | 11.2 |
| 2023-07 | 0 | 9.67 |
| 2023-08 | 0 | 6.67 |
| 2023-09 | 0 | 6.4 |
| 2023-10 | 0 | 7.25 |
| 2023-11 | 0 | 14 |
| 2023-12 | 0 | 6.25 |
| 2024-01 | 0 | 14.75 |
| 2024-02 | 0 | 5.6 |
| 2024-03 | 0 | 7.75 |
| 2024-04 | 0 | 5.2 |
| 2024-05 | 0 | 3.6 |
| 2024-06 | 0 | 7 |
| 2024-07 | 0 | 5.17 |
| 2024-08 | 0 | 5 |
| 2024-09 | 0 | 8 |
| 2024-10 | 0 | 7.33 |
| 2024-11 | 0 | 3.8 |
| 2024-12 | 0 | 4.83 |
| 2025-01 | 0 | 5.4 |
| 2025-02 | 0 | 3 |
| 2025-03 | 0 | 4.2 |
| 2025-04 | 0 | 3.83 |
| 2025-05 | 0 | 2.6 |
| 2025-06 | 0 | 4.33 |
| 2025-07 | 0 | 6.25 |
| 2025-08 | 0 | 5.33 |
| 2025-09 | 0 | 3 |
| 2025-10 | 0 | 3.2 |
| 2025-11 | 0 | 3.43 |
| 2025-12 | 0 | 3 |
| 2026-01 | 0 | 3 |
| 2026-02 | 0 | 2.75 |
| 2026-03 | 0 | 2.6 |
| 2026-04 | 0 | 6 |
| 2026-05 | 0 | 3.33 |
| 2026-06 | 0 | 3 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-04-11 | Z-1717-2025 | 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. | 1,840 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-06-09 | 3014334038-2023-00094 | Injury | Available | exact di |
| 2022-12-21 | 3014334038-2022-00285 | Injury | Available | exact di |
| 2022-08-02 | 3014334038-2022-00174 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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