EXCOR Adverse Events: FDA MAUDE Data

Berlin Heart GmbH · Ventricular Assist Device (LVAD) · First cleared Jun 2017 · 42 device variants grouped

Total Reports

619

Reports (30d)

7

Active Signals

4

Open Recalls

1

Monthly Report Volume
Event Type Breakdown

Active safety signals

Disproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghigh

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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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.