MAUDE manufacturer profile
MEDTRONIC HEART VALVE DIVISION · LWR
MAUDE profile for Heart-Valve, Non-Allograft Tissue
Key facts
| Manufacturer | MEDTRONIC HEART VALVE DIVISION |
|---|---|
| Manufacturer group | MEDTRONIC HEART VALVE DIVISION |
| 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
- 10–99 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Information, Aortic Valve Stenosis, Adverse Event Without Identified Device or Use Problem, Aortic Regurgitation, Aortic Insufficiency, Gradient Increase 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