HEARTWARE SHOULDER PACK Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Ventricular Assist Device (LVAD)

Total Reports

533

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

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

Class II

Oct 31, 2023 · Open, Classified

Class II

Oct 31, 2023 · Open, Classified

Class II

Oct 31, 2023 · Open, Classified

Class II

Oct 31, 2023 · Open, Classified

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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.