MAUDE manufacturer profile
CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) · MCX
MAUDE profile for Catheter, Coronary, Atherectomy
Key facts
| Manufacturer | CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) |
|---|---|
| Manufacturer group | CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) |
| Product code | MCX |
| Product code name | Catheter, Coronary, Atherectomy |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 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, Myocardial Infarction, Entrapment of Device, Low Blood Pressure/ Hypotension, Appropriate Term / Code Not Available 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