MAUDE manufacturer profile
MEDTRONIC HEART VALVES DIVISION · DYE
MAUDE profile for Replacement Heart-Valve
Key facts
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
|---|---|
| Manufacturer group | MEDTRONIC HEART VALVES DIVISION |
| Product code | DYE |
| Product code name | Replacement Heart-Valve |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Insufficient Information, Aortic Valve Stenosis, Aortic Valve Insufficiency/ Regurgitation, Gradient Increase, Intravalvular regurgitation, Device Stenosis, No Information 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