MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · DRF
MAUDE profile for Catheter, Electrode Recording, Or Probe, Electrode Recording
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | DRF |
| Product code name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Pericardial Effusion, Cardiac Tamponade, Low Blood Pressure/ Hypotension, No Consequences Or Impact To Patient, Material Integrity Problem, Cardiac Perforation 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