MAUDE brand profile
SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY IVL SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | SHOCKWAVE C2 PLUS CORONARY INTRAVASCULAR LITHOTRIPSY IVL SYSTEM |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Arrhythmia, Cardiac Arrest, Failure to Cycle, Difficult to Remove, Material Rupture, Low Cardiac Output, Air Embolism 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