ClaripulseClaripulse
MAUDE Lookup

Guides

FDA MAUDE DatabasePost-Market SurveillanceSafety Signal DetectionISO 14971 Risk ManagementAll guides →

More

BlogReports & ResearchWhy Claripulse?
LoginGet Early Access
ClaripulseClaripulse

Product

MAUDE LookupDashboard

Guides

FDA MAUDE DatabasePost-Market SurveillanceSafety Signal DetectionISO 14971 Risk ManagementAll guides

Learn

BlogReports & ResearchWhy Claripulse?

Legal

Privacy PolicyTerms of Service

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.

Back to Mechanical Circulatory Support
MAUDE LookupMechanical Circulatory SupportHVAD PUMP IMPLANT KIT

HVAD PUMP IMPLANT KIT Adverse Events: FDA MAUDE Data

Heartware Inc. · Ventricular Assist Device (LVAD)

Total Reports

220

Reports (30d)

219

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Cardiac Arrhythmia Requiring Intervention

data registry, report event, registry does, device vad, reported intermacs

47

reports

2

Fluid Overload Hospitalization

data registry, event event, contain device, device vad, possible information

28

reports

3

Bacterial Bloodstream Infection Treatment

data registry, correlated previously, device identifying, device vad, likely available

17

reports

4

Driveline Infection Requiring IV Treatment

data registry, information likely, device analysis, device vad, possible information

16

reports

5

Major Upper Gastrointestinal Bleed

data registry, event event, gastrointestinal, bleed, device vad

13

reports

6

Gastrointestinal Bleed Hospitalization

data registry, patient complications, gastrointestinal, bleed, device vad

11

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

New problem typehigh

Keep exploring

Related devices in MCS

Impella

Abiomed, Inc. · 39,669 reports

→

HVAD Pump Implant Kit

MEDTRONIC, INC. · 37,288 reports

→

HeartMate 3

Thoratec Corporation · 22,735 reports

→

HeartMate

Thoratec Corporation · 16,160 reports

→

CARDIOSAVE HYBRID, TYPE B PLUG

Datascope Corp. · 13,030 reports

→

THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

Thoratec Corporation · 7,171 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.

Get Early Access

Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

→

How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

→
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.