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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse™.

FDA Database

MAUDE Adverse Event Search

174,617 reports · 32 product codes · Updated weekly

Jump toTop devicesBrowse by category

Most-reported devices

The 20 devices with the most MAUDE reports across all categories.

Browse by category

CAPSUREFIX Novus

MEDTRONIC, INC.

#1

46,344

reports

253 in 30d

Impella

Abiomed, Inc.

#2

44,096

reports

986 in 30d

Sprint Quattro Secure S MRI SureScan

MEDTRONIC, INC.

#3

39,133

Browse by category

Top devices

CRM

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

65,995

reports

230

devices

MCS

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

59,255

reports

323

devices

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.

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New to MAUDE?

FDA MAUDE Database: what it is and how to use it

The plain-English overview: what MAUDE holds, how to search it, and the limits to know before you trust the counts.

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How to search the FDA MAUDE database

A hands-on walkthrough of the queries that work and what raw MAUDE will not tell you.

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Frequently asked questions

What is the FDA MAUDE database?+

MAUDE (Manufacturer and User Facility Device Experience) is the FDA's public database of medical device adverse event reports submitted by manufacturers, importers, device user facilities, and the public. It is the most comprehensive public source of device safety reports in the United States.

Is this MAUDE search tool free?+

Yes. This lookup tool is free to use. It reads the same publicly available openFDA data and refreshes weekly.

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.

reports

556 in 30d

EMBLEM S-ICD

BOSTON SCIENTIFIC CORPORATION

#4

39,062

reports

338 in 30d

HVAD PUMP IMPLANT KIT

MEDTRONIC, INC.

#5

33,490

reports

0 in 30d

CapSureFix Novus MRI SureScan

MEDTRONIC, INC.

#6

29,710

reports

357 in 30d

Perclose ProGlide

ABBOTT VASCULAR INC.

#7

24,665

reports

13 in 30d

HeartMate 3

Thoratec Corporation

#8

24,385

reports

374 in 30d

Durata

ABBOTT (ST. JUDE MEDICAL)

#9

20,458

reports

132 in 30d

Perclose ProStyle

ABBOTT VASCULAR INC.

#10

19,648

reports

53 in 30d

MitraClip

ABBOTT VASCULAR INC.

#11

18,874

reports

201 in 30d

HeartMate

Thoratec Corporation

#12

16,874

reports

135 in 30d

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Edwards Lifesciences LLC

#13

13,813

reports

194 in 30d

CARDIOSAVE HYBRID, TYPE B PLUG

Datascope Corp.

#14

13,675

reports

167 in 30d

Evolut FX

MEDTRONIC, INC.

#15

13,556

reports

256 in 30d

Quadra Assura MP

ABBOTT (ST. JUDE MEDICAL)

#16

10,671

reports

22 in 30d

LINQ II

MEDTRONIC, INC.

#17

10,214

reports

209 in 30d

PERCLOSE

ABBOTT VASCULAR INC.

#18

10,164

reports

39 in 30d

Gallant CRT-D

ABBOTT (ST. JUDE MEDICAL)

#19

9,362

reports

157 in 30d

Quartet

ABBOTT (ST. JUDE MEDICAL)

#20

8,753

reports

67 in 30d

Structural

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

26,291

reports

64

devices

Coronary

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

17,098

reports

144

devices

Ablation

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

5,909

reports

116

devices

EP Mapping

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

63

reports

117

devices

HF/Neuromod

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

6

reports

6

devices

How often is the data updated?+

We pull from the openFDA API every week, so the device counts and timelines reflect the most recent reports the FDA has published.

Does a high number of adverse event reports mean a device is unsafe?+

No. MAUDE is passive surveillance, so report counts reflect reporting behavior rather than true event rates. Counts can be affected by sales volume, publicity, and recalls. Use the data to spot patterns worth investigating, not to rank devices by safety.

Which devices can I look up here?+

This tool covers 32 cardiac device types across eight categories, including pacemakers and ICDs, ablation catheters, TAVR and structural heart devices, coronary stents, and mechanical circulatory support devices such as Impella and LVADs.