FDA Database

MAUDE Adverse Event Search

112,483 reports · 32 product codes · Updated weekly

Categories

CRM

Pacemakers, ICDs, CRT devices, leads, and insertable cardiac monitors — adverse event trends and safety signals.

90,137

reports

269

devices

Structural

TAVR valves, surgical/transcatheter valves, MitraClip, tricuspid repair, septal occluders, and LAA closure devices.

9,866

reports

devices

Coronary

Drug-eluting stents, intravascular lithotripsy, IVUS, OCT, and vascular closure devices.

5,558

reports

208

devices

MCS

IABP, Impella, LVAD (HeartMate), and ventricular bypass device adverse event data.

2,662

reports

145

devices

Ablation

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

2,461

reports

114

devices

EP Mapping

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

1,748

reports

196

devices

HF/Neuromod

Cardiac contractility modulation (CCM) and carotid sinus nerve stimulation (Barostim) adverse events.

reports

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.