MAUDE manufacturer profile
CARDIOVASCULAR SYSTEMS INCORPORATED · MCX
MAUDE profile for Catheter, Coronary, Atherectomy
Key facts
| Manufacturer | CARDIOVASCULAR SYSTEMS INCORPORATED |
|---|---|
| Manufacturer group | CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232 |
| Product code | MCX |
| Product code name | Catheter, Coronary, Atherectomy |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Material Separation, Foreign Body In Patient, Perforation of Vessels, Vascular Dissection, Death, Entrapment of Device, No Clinical Signs, Symptoms or Conditions 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