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.
19 linked reportsMalfunction 19
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.2 |
| 2019-02 | 0 | 1.4 |
| 2019-03 | 0 | 1.5 |
| 2019-04 | 0 | 2.1 |
| 2019-05 | 0 | 1.57 |
| 2019-06 | 0 | 1.17 |
| 2019-07 | 0 | 1.64 |
| 2019-08 | 0 | 2.6 |
| 2019-09 | 0 | 2.2 |
| 2019-10 | 0 | 3 |
| 2019-11 | 0 | 2.43 |
| 2019-12 | 1 | 1.56 |
| 2020-01 | 0 | 1.25 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 2.25 |
| 2020-04 | 0 | 1.89 |
| 2020-05 | 0 | 3.5 |
| 2020-06 | 0 | 6.38 |
| 2020-07 | 0 | 4.25 |
| 2020-08 | 0 | 4 |
| 2020-09 | 0 | 4.91 |
| 2020-10 | 0 | 2.95 |
| 2020-11 | 0 | 12.5 |
| 2020-12 | 0 | 2.45 |
| 2021-01 | 0 | 2.2 |
| 2021-02 | 0 | 1.5 |
| 2021-03 | 0 | 2.64 |
| 2021-04 | 0 | 1.4 |
| 2021-05 | 0 | 2.22 |
| 2021-06 | 0 | 1.38 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2.67 |
| 2021-09 | 0 | 3.23 |
| 2021-10 | 0 | 2.54 |
| 2021-11 | 0 | 3.29 |
| 2021-12 | 0 | 2.45 |
| 2022-01 | 0 | 2.83 |
| 2022-02 | 0 | 1.71 |
| 2022-03 | 0 | 3.18 |
| 2022-04 | 0 | 2.8 |
| 2022-05 | 0 | 2.67 |
| 2022-06 | 0 | 2.4 |
| 2022-07 | 0 | 2.86 |
| 2022-08 | 0 | 2.56 |
| 2022-09 | 0 | 2.14 |
| 2022-10 | 0 | 2.43 |
| 2022-11 | 1 | 1.9 |
| 2022-12 | 0 | 2.53 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1.93 |
| 2023-03 | 0 | 3.13 |
| 2023-04 | 0 | 3.14 |
| 2023-05 | 0 | 2.25 |
| 2023-06 | 0 | 3.29 |
| 2023-07 | 4 | 2.57 |
| 2023-08 | 2 | 2.53 |
| 2023-09 | 0 | 2.38 |
| 2023-10 | 0 | 2.79 |
| 2023-11 | 1 | 2.3 |
| 2023-12 | 0 | 1.78 |
| 2024-01 | 0 | 1.42 |
| 2024-02 | 0 | 2.15 |
| 2024-03 | 0 | 2.08 |
| 2024-04 | 0 | 2.46 |
| 2024-05 | 0 | 1.36 |
| 2024-06 | 0 | 2.9 |
| 2024-07 | 0 | 1.75 |
| 2024-08 | 0 | 1.9 |
| 2024-09 | 0 | 3.07 |
| 2024-10 | 4 | 2.5 |
| 2024-11 | 0 | 5.33 |
| 2024-12 | 0 | 6.31 |
| 2025-01 | 0 | 2.14 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 3.07 |
| 2025-04 | 0 | 2.53 |
| 2025-05 | 0 | 7.53 |
| 2025-06 | 0 | 1.78 |
| 2025-07 | 0 | 3.12 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 3.27 |
| 2025-10 | 3 | 2.75 |
| 2025-11 | 1 | 2.56 |
| 2025-12 | 0 | 2 |
| 2026-01 | 1 | 1.75 |
| 2026-02 | 0 | 3.77 |
| 2026-03 | 1 | 3.09 |
| 2026-04 | 0 | 5.55 |
| 2026-05 | 0 | 4.93 |
| 2026-06 | 0 | 3.41 |
Failure-mode summaryAI-generated
19 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-01-19 | Z-1168-2021 | Class II | Open, Classified | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.Distribution: US nationwide distribution. | 335,788 units total (Domestic: 222,882, Foreign: 112,906) | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-06 | 3005099803-2026-00850 | Malfunction | Available | exact di |
| 2026-01-08 | 3005099803-2026-00121 | Malfunction | Available | exact di |
| 2025-11-21 | 3005099803-2025-06267 | Malfunction | Available | exact di |
| 2025-10-30 | 3005099803-2025-05612 | Malfunction | Available | exact di |
| 2025-10-07 | 3005099803-2025-05083 | Malfunction | Available | exact di |
| 2025-10-07 | 3005099803-2025-05082 | Malfunction | Available | exact di |
| 2024-10-28 | 3005099803-2024-05400 | Malfunction | Available | exact di |
| 2024-10-28 | 3005099803-2024-05399 | Malfunction | Available | exact di |
| 2024-10-28 | 3005099803-2024-05401 | Malfunction | Available | exact di |
| 2024-10-28 | 3005099803-2024-05398 | Malfunction | Available | exact di |
| 2023-11-17 | 3005099803-2023-06266 | Malfunction | Available | exact di |
| 2023-08-16 | 3005099803-2023-04312 | Malfunction | Available | exact di |
| 2023-08-08 | 3005099803-2023-04220 | Malfunction | Available | exact di |
| 2023-07-13 | 3005099803-2023-03766 | Malfunction | Available | exact di |
| 2023-07-13 | 3005099803-2023-03765 | Malfunction | Available | exact di |
Showing 1–15 of 19
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-04-07 | OAI | Official action indicated | Boston Scientific Corporation | 9 |
| 2025-04-07 | OAI | Official action indicated | Boston Scientific Corporation | 9 |
| 2025-03-18 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2025-03-18 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2024-12-06 | NAI | No action indicated | Nalu Medical, Inc. | 0 |
| 2024-11-26 | VAI | Voluntary action indicated | Boston Scientific Corporation | 3 |
| 2024-11-26 | VAI | Voluntary action indicated | Boston Scientific Corporation | 3 |
| 2024-06-13 | NAI | No action indicated | Elutia Inc | 0 |
| 2024-01-23 | VAI | Voluntary action indicated | Silk Road Medical | 1 |
| 2023-12-05 | NAI | No action indicated | Valencia Technologies Corporation | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Corbin Clinical Resources, Llc | 1 |
| 2023-08-01 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2023-08-01 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2023-04-05 | NAI | No action indicated | Intera Oncology, Inc. | 0 |
| 2022-07-28 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2022-07-28 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2022-06-02 | VAI | Voluntary action indicated | Boston Scientific de Costa Rica SRL | 0 |
| 2022-03-23 | NAI | No action indicated | Axonics, Inc. | 0 |
| 2021-11-17 | VAI | Voluntary action indicated | Valencia Technologies Corporation | 1 |
| 2021-10-29 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2014-04-10 | WL | Warning Letter | Boston Scientific Corporation | — |
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