MAUDE manufacturer profile
ABIOMED, INC · OJE
MAUDE profile for Right Ventricular Bypass (Assist) Device
Key facts
| Manufacturer | ABIOMED, INC |
|---|---|
| Manufacturer group | ABIOMED, INC |
| Product code | OJE |
| Product code name | Right Ventricular Bypass (Assist) Device |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Thrombus, Device Operates Differently Than Expected, Death, Adverse Event Without Identified Device or Use Problem, Hematoma, Blood Loss, Perforation, Difficult to Advance 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