Electrophysiology: Mapping Adverse Event Data
High-density intracardiac mapping and EP diagnostic catheter adverse event reports.
Total Reports
6,050
Devices Tracked
200
Reports (30d)
52
Active Signals
4
Devices in EP Mapping
| Device | Total Reports | Last 30d |
|---|---|---|
ACHIEVE™DRF | 1,231 | 0 |
PENTARAY NAVMTD | 606 | 12 |
| 439 | 5 | |
| 415 | 1 | |
| 344 | 2 | |
PENTARAY NAVMTD | 282 | 2 |
| 167 | 2 | |
DECANAVDRF | 141 | 1 |
| 133 | 1 | |
ACHIEVE™DRF | 106 | 8 |
DECANAVDRF | 96 | 1 |
INQUIRY STEERABLE DIAGNOSTIC CATHETERDRF | 80 | 1 |
| 74 | 3 | |
Advisor™DRF | 73 | 0 |
PENTARAY NAVMTD | 72 | 1 |
POLARMAP™DRF | 69 | 1 |
NaviStarDRF | 62 | 1 |
LASSO NAVDRF | 61 | 0 |
| 58 | 0 | |
LassoDRF | 55 | 0 |
Inquiry™DRF | 55 | 0 |
| 52 | 1 | |
OPTRELL Mapping Catheter with TRUEref TechnologyMTD | 50 | 2 |
Advisor™ HD Grid X, Sensor Enabled™MTD | 42 | 1 |
Dynamic XT™DRF | 41 | 1 |
1–25 of 200 devices
All EP Mapping device pages (11)
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 4 active signals detected right now.
Get Early AccessUnderstanding this data
What FDA MAUDE data does and does not tell you
How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.
How a safety signal is detected
What the "Active Signals" count above means and the methods that separate a real signal from noise.
Post-market surveillance: a practical guide
Where MAUDE fits in the wider regulatory picture and the data sources teams rely on.