MAUDE brand profile
HEARTMATE II LVAS IMPLANT KIT WITH SEALED GRAFTS
MAUDE brand safety profile
Key facts
| Brand name | HEARTMATE II LVAS IMPLANT KIT WITH SEALED GRAFTS |
|---|
At a glance
- 1,000+ MAUDE reports
- 1,000+ Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Mechanical Problem, Insufficient Information, No Clinical Signs, Symptoms or Conditions, Pumping Stopped, Infusion or Flow Problem, No Consequences Or Impact To Patient, Decreased Pump Speed 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