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THORATEC HEARTMATE, SYSTEM MONITOR Adverse Events: FDA MAUDE Data

Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Mar 2003 · 2 device variants grouped

Total Reports

443

Reports (30d)

0

Active Signals

1

Open Recalls

11

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Power Interruption with No Pump Support

unit mpu, captured, external power, mpu, mobile power

1

reports

2

System Controller Exchange After Alarm

primary, connected, unusual, review log, files submitted

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 reportingmedium

Regulatory

FDA recalls for this device

Class II

May 13, 2026 · Open, Classified

Due to 11 volt Backup Battery failures.

Class II

May 13, 2026 · Open, Classified

Due to 11 volt Backup Battery failures.

Class II

May 13, 2026 · Open, Classified

Due to 11 volt Backup Battery failures.

Class II

Oct 9, 2025 · Open, Classified

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Class II

Oct 9, 2025 · Open, Classified

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Class II

Oct 9, 2025 · Open, Classified

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Evidence

Related research

A Review of New-Onset Ventricular Arrhythmia after Left Ventricular Assist Device Implantation

Jian‐Wei Shi, et al. · Cardiology · 2022

Citations indexed from PubMed.

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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.