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.
21 linked reportsMalfunction 21
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.08 |
| 2019-02 | 0 | 1.33 |
| 2019-03 | 0 | 1.56 |
| 2019-04 | 0 | 2.5 |
| 2019-05 | 0 | 1.57 |
| 2019-06 | 1 | 1.14 |
| 2019-07 | 0 | 1.58 |
| 2019-08 | 0 | 2.73 |
| 2019-09 | 0 | 2.07 |
| 2019-10 | 0 | 2.7 |
| 2019-11 | 0 | 3.13 |
| 2019-12 | 0 | 2 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 0 | 2.73 |
| 2020-03 | 0 | 2.5 |
| 2020-04 | 0 | 1.8 |
| 2020-05 | 0 | 3.5 |
| 2020-06 | 0 | 5.78 |
| 2020-07 | 1 | 3.6 |
| 2020-08 | 3 | 3.58 |
| 2020-09 | 0 | 4.62 |
| 2020-10 | 0 | 3 |
| 2020-11 | 2 | 9 |
| 2020-12 | 1 | 2.69 |
| 2021-01 | 0 | 2.15 |
| 2021-02 | 0 | 1.4 |
| 2021-03 | 0 | 2.58 |
| 2021-04 | 1 | 1.42 |
| 2021-05 | 0 | 2.27 |
| 2021-06 | 0 | 1.32 |
| 2021-07 | 1 | 2 |
| 2021-08 | 0 | 2.5 |
| 2021-09 | 0 | 3 |
| 2021-10 | 0 | 2.94 |
| 2021-11 | 0 | 2.8 |
| 2021-12 | 1 | 2.29 |
| 2022-01 | 1 | 3.2 |
| 2022-02 | 0 | 2.44 |
| 2022-03 | 1 | 3.65 |
| 2022-04 | 0 | 2.69 |
| 2022-05 | 0 | 2.73 |
| 2022-06 | 0 | 2.28 |
| 2022-07 | 0 | 2.79 |
| 2022-08 | 0 | 2.8 |
| 2022-09 | 0 | 2.63 |
| 2022-10 | 0 | 2.5 |
| 2022-11 | 0 | 1.83 |
| 2022-12 | 0 | 2.89 |
| 2023-01 | 3 | 1.94 |
| 2023-02 | 0 | 2 |
| 2023-03 | 1 | 2.76 |
| 2023-04 | 0 | 2.64 |
| 2023-05 | 0 | 2.23 |
| 2023-06 | 0 | 3.33 |
| 2023-07 | 0 | 2.47 |
| 2023-08 | 0 | 2.41 |
| 2023-09 | 0 | 2.25 |
| 2023-10 | 0 | 2.53 |
| 2023-11 | 0 | 2.33 |
| 2023-12 | 0 | 2.08 |
| 2024-01 | 0 | 1.67 |
| 2024-02 | 0 | 2.29 |
| 2024-03 | 0 | 2.56 |
| 2024-04 | 0 | 2.73 |
| 2024-05 | 0 | 1.36 |
| 2024-06 | 0 | 3 |
| 2024-07 | 0 | 2.18 |
| 2024-08 | 0 | 1.85 |
| 2024-09 | 4 | 3.41 |
| 2024-10 | 0 | 2.44 |
| 2024-11 | 0 | 4.62 |
| 2024-12 | 0 | 5.79 |
| 2025-01 | 0 | 3.89 |
| 2025-02 | 0 | 3.91 |
| 2025-03 | 0 | 3.94 |
| 2025-04 | 0 | 3.29 |
| 2025-05 | 0 | 8.26 |
| 2025-06 | 0 | 2.8 |
| 2025-07 | 0 | 3.52 |
| 2025-08 | 0 | 3.41 |
| 2025-09 | 0 | 3.89 |
| 2025-10 | 0 | 4.59 |
| 2025-11 | 0 | 3.91 |
| 2025-12 | 0 | 3.56 |
| 2026-01 | 0 | 2.75 |
| 2026-02 | 0 | 4.06 |
| 2026-03 | 0 | 4.38 |
| 2026-04 | 0 | 5.06 |
| 2026-05 | 0 | 6.06 |
| 2026-06 | 0 | 4.18 |
Failure-mode summaryAI-generated
21 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-01-19 | Z-1169-2021 | 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 |
|---|---|---|---|---|
| 2024-09-25 | 3005099803-2024-04697 | Malfunction | Available | exact di |
| 2024-09-13 | 3005099803-2024-04498 | Malfunction | Available | exact di |
| 2024-09-02 | 3005099803-2024-04163 | Malfunction | Available | exact di |
| 2024-09-02 | 3005099803-2024-04160 | Malfunction | Available | exact di |
| 2023-03-09 | 3005099803-2023-01244 | Malfunction | Available | exact di |
| 2023-01-05 | 3005099803-2022-07861 | Malfunction | Available | exact di |
| 2023-01-05 | 3005099803-2022-07856 | Malfunction | Available | exact di |
| 2023-01-05 | 3005099803-2022-07859 | Malfunction | Available | exact di |
| 2022-03-28 | 3005099803-2022-01494 | Malfunction | Available | exact di |
| 2022-01-13 | 3005099803-2021-08150 | Malfunction | Available | exact di |
| 2021-12-29 | 3005099803-2021-08011 | Malfunction | Available | exact di |
| 2021-07-06 | 3005099803-2021-03238 | Malfunction | Available | exact di |
| 2021-04-07 | 3005099803-2021-01325 | Malfunction | Available | exact di |
| 2020-12-16 | 3005099803-2020-05877 | Malfunction | Available | exact di |
| 2020-11-05 | 3005099803-2020-05064 | Malfunction | Available | exact di |
Showing 1–15 of 21
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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