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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

84,077 reports · 32 product codes · Updated weekly

46 results for “evolut”

Evolut™ FX

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

3,496

reports

249

last 30d

View category

CoreValve™ Evolut™ R

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

3,473

reports

33

last 30d

View category

Evolut™ PRO+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

2,987

reports

31

last 30d

View category

Evolut™ FX

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

2,094

reports

0

last 30d

View category

Evolut™ FX

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

1,685

reports

1

last 30d

View category

Evolut™ FX

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

1,448

reports

2

last 30d

View category

Evolut™ PRO+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

1,404

reports

5

last 30d

View category

Evolut™ FX+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

1,225

reports

11

last 30d

View category

Evolut™ PRO+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

1,175

reports

2

last 30d

View category

Evolut™ FX

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

1,132

reports

0

last 30d

View category

Evolut™ FX+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

833

reports

6

last 30d

View category

Evolut™ FX+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

781

reports

8

last 30d

View category

CoreValve™ Evolut™ PRO

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

743

reports

1

last 30d

View category

Evolut™ PRO+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

602

reports

0

last 30d

View category

Evolut™ FX

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

477

reports

0

last 30d

View category

Evolut™ FX

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

414

reports

0

last 30d

View category

CoreValve™ Evolut™ PRO

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

395

reports

0

last 30d

View category

Evolut™ PRO+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

338

reports

0

last 30d

View category

CoreValve™ Evolut™ R

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

277

reports

2

last 30d

View category

Evolut™ FX+

NPT

MEDTRONIC, INC.

Transcatheter Aortic Valve (TAVR)

245

reports

2

last 30d

View category
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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.
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.