MAUDE manufacturer profile
VOLCANO CORPORATION · PDU
MAUDE profile for Catheter For Crossing Total Occlusions
Key facts
| Manufacturer | VOLCANO CORPORATION |
|---|---|
| Manufacturer group | VOLCANO CORPORATION |
| Product code | PDU |
| Product code name | Catheter For Crossing Total Occlusions |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Material Separation, No Known Impact Or Consequence To Patient, No Display/Image, Entrapment of Device, Sharp Edges, Adverse Event Without Identified Device or Use Problem, Bent 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