Electrophysiology: Ablation Adverse Event Data

Cardiac ablation catheters including AF, flutter, and pulsed-field ablation adverse event data.

Total Reports

26,587

Devices Tracked

200

Reports (30d)

649

Active Signals

123

Monthly Report Volume

Event Type Breakdown

Devices in Ablation

Device	Manufacturer	Type	Total Reports	Last 30d
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	3,799	54
FARAWAVE™QZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	1,884	80
Arctic Front Advance Pro™OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	1,662	15
FARAWAVE™QZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	1,504	57
PulseSelect™QZI	MEDTRONIC, INC.	Cardiac Ablation Catheter (Pulsed Field/PFA)	1,404	95
TactiCath™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	1,035	4
ThermoCool SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	1,010	0
QDOT MICROOAD	Biosense Webster Inc	Cardiac Ablation Catheter for Atrial Flutter	909	18
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	684	5
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	544	1
Arctic Front®OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	541	2
Arctic Front Advance™OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	509	0
IntellaNav™ Open-IrrigatedOAD	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Flutter	505	0
ThermoCool SmartTouchLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	447	2
INTELLANAV STABLEPOINT™OAE	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Fibrillation	426	1
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	327	3
AFFERAQZI	MEDTRONIC, INC.	Cardiac Ablation Catheter (Pulsed Field/PFA)	319	51
VARIPULSE™ Bi-Directional CatheterQZI	Biosense Webster Inc	Cardiac Ablation Catheter (Pulsed Field/PFA)	308	35
Blazer® IILPB	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Percutaneous)	299	0
ThermoCool SmartTouchLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	291	1
TactiFlex™ Sensor Enabled™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	281	8
TactiCath™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	275	2
IntellaNav MiFi™ Open-IrrigatedOAD	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Flutter	273	1
FARAWAVE™ NAVQZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	254	32
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	251	3

1–25 of 200 devices

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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.