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HVAD Pump Implant Kit Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Ventricular Assist Device (LVAD) · First cleared Nov 2012 · 2 device variants grouped

Total Reports

37,256

Reports (30d)

62

Active Signals

4

Open Recalls

69

Monthly Report Volume

No timeline data available.

Event Type Breakdown

No event type data available.

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Unspecified Hematological Issue Reported

received report, data registry, vad, registry does, device vad

101

reports

2

Motor Start Event with Fault Alarms

battery, vad, device vad, alarm, alarms

48

reports

3

Gastrointestinal Bleed Reported

received report, data registry, device vad, possible information, likely available

35

reports

4

Fluid Overload Requiring Intervention

received report, data registry, registry does, device vad, possible information

29

reports

5

Patient Deaths with Unknown Causes

outcomes, registry, vad, left ventricular, patients

19

reports

6

CNS Injury Including Stroke

received report, data registry, registry does, device vad, possible information

19

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 reportinghighDisproportionate reportinghighVolume spikecriticalIncreasing trendcritical

Regulatory

FDA recalls for this device

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Class II

Oct 31, 2023 · Open, Classified

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Evidence

Related research

A Shocking Discovery

Mary Quien, et al. · JACC Case Reports · 2024

Mechanical Device Malfunction of the HeartMate II Versus the HeartMate 3 Left Ventricular Assist Device: The Rotterdam Experience

Cornelis W. van der Heiden, et al. · ASAIO Journal · 2022

Evolutionary game analysis on the regulation of medical devices used in health services delivery.

Tong G, et al. · 2024

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.

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.