MAUDE manufacturer profile
EDWARDS LIFESCIENCES · DXE
MAUDE profile for Catheter, Embolectomy
Key facts
| Manufacturer | EDWARDS LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES PR |
| Product code | DXE |
| Product code name | Catheter, Embolectomy |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Break, Insufficient Information, Material Rupture, No Consequences Or Impact To Patient, Foreign Body In Patient, Detachment of Device or Device Component, Inflation Problem 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