MAUDE manufacturer profile
IMPELLA CP · OZD
MAUDE profile for Temporary Non-Roller Type Left Heart Support Blood Pump
Key facts
| Manufacturer | IMPELLA CP |
|---|---|
| Manufacturer group | ABIOMED, INC. |
| Product code | OZD |
| Product code name | Temporary Non-Roller Type Left Heart Support Blood Pump |
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
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Hemorrhage/Blood Loss/Bleeding, Deformation Due to Compressive Stress, Patient-Device Incompatibility, Pumping Stopped, Activation, Positioning or Separation Problem, Failure 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