MAUDE manufacturer profile
ST. JUDE MEDICAL, COSTA RICA LTDA · LWR
MAUDE profile for Heart-Valve, Non-Allograft Tissue
Key facts
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Product code | LWR |
| Product code name | Heart-Valve, Non-Allograft Tissue |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Material Split, Cut or Torn, Aortic Insufficiency, Aortic Regurgitation, Obstruction of Flow, Backflow, Aortic Valve Stenosis, Insufficient Information, Adverse Event Without Identified Device or Use 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