MAUDE brand profile
RX HERCULINK ELITE STENT SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | RX HERCULINK ELITE STENT SYSTEM |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Device Dislodged or Dislocated, No Clinical Signs, Symptoms or Conditions, Failure to Advance, Difficult to Remove, Improper or Incorrect Procedure or Method, Material Deformation, Off-Label Use Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1