Electrophysiology: Mapping Adverse Event Data

High-density intracardiac mapping and EP diagnostic catheter adverse event reports.

Total Reports

5,698

Devices Tracked

200

Reports (30d)

Active Signals

Monthly Report Volume

Event Type Breakdown

Devices in EP Mapping

Device	Manufacturer	Type	Total Reports	Last 30d
ACHIEVE™DRF	MEDTRONIC, INC.	Catheter, Electrode Recording (EP Diagnostic)	1,198	7
PENTARAY NAVMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	541	15
IntellaMap Orion™DRF	BOSTON SCIENTIFIC CORPORATION	Catheter, Electrode Recording (EP Diagnostic)	416	9
Advisor™ HD Grid, Sensor Enabled™DRF	ABBOTT (ST. JUDE MEDICAL)	Catheter, Electrode Recording (EP Diagnostic)	406	1
ACHIEVE ADVANCE™DRF	MEDTRONIC, INC.	Catheter, Electrode Recording (EP Diagnostic)	333	3
PENTARAY NAVMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	268	5
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	149	4
DECANAVDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	122	2
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	112	5
ACHIEVE™DRF	MEDTRONIC, INC.	Catheter, Electrode Recording (EP Diagnostic)	97	0
DECANAVDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	88	2
INQUIRY STEERABLE DIAGNOSTIC CATHETERDRF	ABBOTT (ST. JUDE MEDICAL)	Catheter, Electrode Recording (EP Diagnostic)	79	0
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	78	1
Advisor™DRF	ABBOTT (ST. JUDE MEDICAL)	Catheter, Electrode Recording (EP Diagnostic)	76	0
POLARMAP™DRF	BOSTON SCIENTIFIC CORPORATION	Catheter, Electrode Recording (EP Diagnostic)	68	0
PENTARAY NAVMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	68	0
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	63	0
LASSO NAVDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	60	0
NaviStarDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	56	1
Inquiry™DRF	IRVINE BIOMEDICAL, INC.	Catheter, Electrode Recording (EP Diagnostic)	55	0
LassoDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	54	0
Dynamic XT™DRF	BOSTON SCIENTIFIC CORPORATION	Catheter, Electrode Recording (EP Diagnostic)	39	0
OPTRELL Mapping Catheter with TRUEref TechnologyMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	39	0
POLARSHEATHDRF	BOSTON SCIENTIFIC CORPORATION	Catheter, Electrode Recording (EP Diagnostic)	36	0
Advisor™ HD Grid X, Sensor Enabled™MTD	ABBOTT (ST. JUDE MEDICAL)	Intracardiac Mapping Catheter, High-Density	31	1

1–25 of 200 devices

1 / 8

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.