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 |
|---|---|---|---|---|
| 2024-11-26 | VAI | Voluntary action indicated | Atrium Medical Corporation | 8 |
| 2024-11-26 | VAI | Voluntary action indicated | Atrium Medical Corporation | 8 |
| 2022-09-06 | VAI | Voluntary action indicated | Atrium Medical Corporation | 0 |
| 2022-09-06 | VAI | Voluntary action indicated | Atrium Medical Corporation | 0 |
| 2020-02-10 | OAI | Official action indicated | Atrium Medical Corporation | 0 |
| 2020-02-10 | OAI | Official action indicated | Atrium Medical Corporation | 0 |
| 2018-08-02 | NAI | No action indicated | Atrium Medical Corporation | 0 |
| 2018-08-02 | NAI | No action indicated | Atrium Medical Corporation | 0 |
| 2016-07-13 | OAI | Official action indicated | Atrium Medical Corporation | 0 |
| 2016-07-13 | OAI | Official action indicated | Atrium Medical Corporation | 0 |
| 2016-01-08 | NAI | No action indicated | Atrium Medical Corporation | 0 |
| 2016-01-08 | NAI | No action indicated | Atrium Medical Corporation | 0 |
| 2013-10-01 | OAI | Official action indicated | Atrium Medical Corporation | 8 |
| 2013-10-01 | OAI | Official action indicated | Atrium Medical Corporation | 8 |
| 2012-10-11 | WL | Warning Letter | Atrium Medical Corporation | — |
| 2012-10-11 | WL | Warning Letter | Atrium Medical Corporation | — |
| 2012-09-07 | OAI | Official action indicated | Atrium Medical Corporation | 5 |
| 2012-09-07 | OAI | Official action indicated | Atrium Medical Corporation | 5 |
| 2010-03-15 | VAI | Voluntary action indicated | Atrium Medical Corporation | 0 |
| 2010-03-15 | VAI | Voluntary action indicated | Atrium Medical Corporation | 0 |
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