HeartWare Waist Pack Adverse Events: FDA MAUDE Data

Heartware Inc. · Ventricular Assist Device (LVAD) · First cleared Apr 2026 · 2 device variants grouped

Total Reports

393

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghighEarly signalhighNew problem typehighDisproportionate reportinghigh

Evidence

Related research

Alkhunaizi MA, et al. · The American journal of case reports · 2021

Jamiolkowski MA, et al. · Biomaterials · 2016

Fox H, et al. · Interactive cardiovascular and thoracic surgery · 2022

Saef J, et al. · Journal of clinical medicine · 2022

Crosby JR, et al. · Artificial organs · 2016

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.

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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.