MAUDE manufacturer profile
ABIOMED, INC. - 1220648 · OZD
MAUDE profile for Temporary Non-Roller Type Left Heart Support Blood Pump
Key facts
| Manufacturer | ABIOMED, INC. - 1220648 |
|---|---|
| Manufacturer group | DANVERS |
| Product code | OZD |
| Product code name | Temporary Non-Roller Type Left Heart Support Blood Pump |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 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, Restricted Flow rate, Ischemia, Malposition of Device, Failure to Advance, Device Sensing Problem 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