MAUDE manufacturer profile
ABBOTT VASCULAR · DRA
MAUDE profile for Catheter, Steerable
Key facts
| Manufacturer | ABBOTT VASCULAR |
|---|---|
| Manufacturer group | ABBOTT VASCULAR, REG # 3005070406 |
| Product code | DRA |
| Product code name | Catheter, Steerable |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Leak/Splash, No Clinical Signs, Symptoms or Conditions, Atrial Perforation, No Consequences Or Impact To Patient, Perforation, No Patient Involvement, Low Blood Pressure/ Hypotension 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