MAUDE manufacturer profile
LIVANOVA CANADA CORP. · DYE
MAUDE profile for Replacement Heart-Valve
Key facts
| Manufacturer | LIVANOVA CANADA CORP. |
|---|---|
| Manufacturer group | LIVANOVA CANADA CORP. |
| Product code | DYE |
| Product code name | Replacement Heart-Valve |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Information, Aortic Insufficiency, Perivalvular Leak, Calcified, Aortic Valve Stenosis, Material Deformation, Death Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1