MAUDE manufacturer profile
ARROW INTERNATIONAL LLC · DRF
MAUDE profile for Catheter, Electrode Recording, Or Probe, Electrode Recording
Key facts
| Manufacturer | ARROW INTERNATIONAL LLC |
|---|---|
| Manufacturer group | ARROW INTERNATIONAL INC. |
| Product code | DRF |
| Product code name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, No Consequences Or Impact To Patient, Insufficient Information, Failure to Capture, Leak/Splash, No Known Impact Or Consequence To Patient, Material Separation 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