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