MAUDE manufacturer profile
ARROW INTERNATIONAL LLC · DSP
MAUDE profile for System, Balloon, Intra-Aortic And Control
Key facts
| Manufacturer | ARROW INTERNATIONAL LLC |
|---|---|
| Manufacturer group | ARROW INTERNATIONAL INC. |
| Product code | DSP |
| Product code name | System, Balloon, Intra-Aortic And Control |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Fluid/Blood Leak, Device Alarm System, Insufficient Information, Inflation Problem, Gas/Air Leak, Material Rupture 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