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 |
|---|---|---|---|---|
| 2024-05-30 | NAI | No action indicated | DeVilbiss Healthcare LLC | 0 |
| 2022-08-17 | OAI | Official action indicated | DeVilbiss Healthcare LLC | 4 |
| 2021-11-23 | WL | Warning Letter | DeVilbiss Healthcare LLC | — |
| 2021-08-25 | OAI | Official action indicated | DeVilbiss Healthcare LLC | 9 |
| 2016-02-24 | VAI | Voluntary action indicated | Drive DeVilbiss Healthcare | 0 |
| 2016-01-28 | NAI | No action indicated | DeVilbiss Healthcare LLC | 0 |
| 2014-07-18 | VAI | Voluntary action indicated | Drive DeVilbiss Healthcare | 3 |
| 2012-10-10 | WL | Warning Letter | Drive DeVilbiss Healthcare | — |
| 2012-08-31 | OAI | Official action indicated | Drive DeVilbiss Healthcare | 8 |
| 2012-02-22 | NAI | No action indicated | DeVilbiss Healthcare LLC | 0 |
| 2010-03-31 | NAI | No action indicated | DeVilbiss Healthcare LLC | 0 |
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