Electrophysiology: Ablation Adverse Event Data

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

Total Reports

26,737

Devices Tracked

200

Reports (30d)

788

Active Signals

103

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)	3,802	27
FARAWAVE™QZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	2,059	163
Arctic Front Advance Pro™OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	1,667	7
FARAWAVE™QZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	1,547	43
PulseSelect™QZI	MEDTRONIC, INC.	Cardiac Ablation Catheter (Pulsed Field/PFA)	1,542	138
TactiCath™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	1,044	9
ThermoCool SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	1,010	0
QDOT MICROOAD	Biosense Webster Inc	Cardiac Ablation Catheter for Atrial Flutter	933	24
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	687	3
Arctic Front®OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	550	7
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	545	1
IntellaNav™ Open-IrrigatedOAD	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Flutter	510	2
Arctic Front Advance™OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	510	1
ThermoCool SmartTouchLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	494	23
INTELLANAV STABLEPOINT™OAE	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Fibrillation	431	3
Sphere-9™ CatheterQZI	MEDTRONIC, INC.	Cardiac Ablation Catheter (Pulsed Field/PFA)	383	61
VARIPULSE™ Bi-Directional CatheterQZI	Biosense Webster Inc	Cardiac Ablation Catheter (Pulsed Field/PFA)	335	27
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	330	3
Blazer® IILPB	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Percutaneous)	299	0
TactiFlex™ Sensor Enabled™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	298	17
FARAWAVE™ NAVQZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	297	43
ThermoCool SmartTouchLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	293	2
TactiCath™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	280	5
IntellaNav MiFi™ Open-IrrigatedOAD	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Flutter	274	1
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	259	8

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.