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EXCOR Adverse Events: FDA MAUDE Data

Berlin Heart GmbH · Ventricular Assist Device (LVAD) · First cleared Nov 2021

Total Reports

210

Reports (30d)

2

Active Signals

0

Open Recalls

1

Monthly Report Volume
Event Type Breakdown

Regulatory

FDA recalls for this device

Class II

Apr 24, 2026 · Open, Classified

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

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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.