MAUDE brand profile
STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
|---|
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Perforation of Vessels, Vascular Dissection, Entrapment of Device, No Code Available, Vascular System (Circulation), Impaired, Material Separation, Vessel Or Plaque, Device Embedded In 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