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 |
|---|---|---|---|---|
| 2025-08-11 | WL | Warning Letter | LeMaitre Vascular, Inc. | — |
| 2025-08-11 | WL | Warning Letter | LeMaitre Vascular, Inc. | — |
| 2025-04-16 | OAI | Official action indicated | LeMaitre Vascular, Inc. | 8 |
| 2025-04-16 | OAI | Official action indicated | LeMaitre Vascular, Inc. | 8 |
| 2023-05-16 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 1 |
| 2023-05-16 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 1 |
| 2023-04-13 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 4 |
| 2023-04-13 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 4 |
| 2022-06-15 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 5 |
| 2022-06-15 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 5 |
| 2020-08-27 | NAI | No action indicated | LeMaitre Vascular, Inc. | 0 |
| 2020-08-27 | NAI | No action indicated | LeMaitre Vascular, Inc. | 0 |
| 2018-02-16 | NAI | No action indicated | LeMaitre Vascular, Inc. | 0 |
| 2018-02-16 | NAI | No action indicated | LeMaitre Vascular, Inc. | 0 |
| 2017-08-01 | NAI | No action indicated | LeMaitre Vascular, Inc. | 0 |
| 2017-08-01 | NAI | No action indicated | LeMaitre Vascular, Inc. | 0 |
| 2015-01-28 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 5 |
| 2015-01-28 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 5 |
| 2013-03-04 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 3 |
| 2013-03-04 | VAI | Voluntary action indicated | LeMaitre Vascular, Inc. | 3 |
| 2013-01-25 | NAI | No action indicated | LeMaitre Vascular, Inc. | 0 |
| 2013-01-25 | NAI | No action indicated | LeMaitre Vascular, Inc. | 0 |
| 2010-05-11 | WL | Warning Letter | LeMaitre Vascular, Inc. | — |
| 2010-05-11 | WL | Warning Letter | LeMaitre Vascular, Inc. | — |
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