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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
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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