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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.

Back to Mechanical Circulatory Support
MAUDE LookupMechanical Circulatory SupportHEARTMATE 3

HEARTMATE 3 Adverse Events: FDA MAUDE Data

ABBOTT (ST. JUDE MEDICAL) · Ventricular Assist Device (LVAD)

Total Reports

162

Reports (30d)

0

Active Signals

2

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Modular Cable Damage at Clinic Visit

driveline, modular, damage, clinic, modular cable

5

reports

2

Driveline Power Fault Alarm Recurrence

speed, fault, driveline, alarm, alarms

1

reports

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

Detection

Active safety signals

Disproportionate reportinghighIncreasing trendmedium

Evidence

Related research

Short-term outcomes of pediatric HeartMate 3 left ventricular assist device: single center experience.

Dawary M, et al. · 2026

Case report: failed restoration of left ventricular function after myosplint® placement followed by successful HeartMate 3™ LVAD implantation.

Schnackenburg P, et al. · 2026

Early right ventricular failure following HeartMate 3 left ventricular assist device implantation: Risk factors and outcomes.

Sayer G, et al. · 2026

Gastrointestinal Bleeding in Patients Who Underwent HeartMate 3 Left Ventricular Assist Device Implantation.

Eisenberger J, et al. · 2026

Long-term outcomes of patients implanted with a HeartMate 3 left ventricular assist device-a real-world, single-centre, observational study.

Legtenberg S, et al. · 2026

Citations indexed from PubMed.

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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.

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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.

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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.