Electrophysiology: Mapping Adverse Event Data

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

Total Reports

5,598

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)	1,206	8
PENTARAY NAVMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	549	9
IntellaMap Orion™DRF	BOSTON SCIENTIFIC CORPORATION	Catheter, Electrode Recording (EP Diagnostic)	418	2
Advisor™ HD Grid, Sensor Enabled™DRF	ABBOTT (ST. JUDE MEDICAL)	Catheter, Electrode Recording (EP Diagnostic)	408	3
ACHIEVE ADVANCE™DRF	MEDTRONIC, INC.	Catheter, Electrode Recording (EP Diagnostic)	336	3
PENTARAY NAVMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	270	2
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	151	3
DECANAVDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	122	1
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	119	7
ACHIEVE™DRF	MEDTRONIC, INC.	Catheter, Electrode Recording (EP Diagnostic)	97	0
DECANAVDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	91	2
Advisor™DRF	ABBOTT (ST. JUDE MEDICAL)	Catheter, Electrode Recording (EP Diagnostic)	72	0
PENTARAY NAVMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	69	0
POLARMAP™DRF	BOSTON SCIENTIFIC CORPORATION	Catheter, Electrode Recording (EP Diagnostic)	68	0
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	65	2
LASSO NAVDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	60	0
NaviStarDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	58	2
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	56	0
Inquiry™DRF	IRVINE BIOMEDICAL, INC.	Catheter, Electrode Recording (EP Diagnostic)	55	0
LassoDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	55	0
OCTARAY Mapping CatheterMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	50	1
OPTRELL Mapping Catheter with TRUEref TechnologyMTD	Biosense Webster Inc	Intracardiac Mapping Catheter, High-Density	41	2
OPTRELLDRF	Biosense Webster Inc	Catheter, Electrode Recording (EP Diagnostic)	40	0
Dynamic XT™DRF	BOSTON SCIENTIFIC CORPORATION	Catheter, Electrode Recording (EP Diagnostic)	39	0
POLARSHEATHDRF	BOSTON SCIENTIFIC CORPORATION	Catheter, Electrode Recording (EP Diagnostic)	36	0

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.