EXCOR Adverse Events: FDA MAUDE Data
Berlin Heart GmbH · Ventricular Assist Device (LVAD) · First cleared Nov 2021
Total Reports
208
Reports (30d)
3
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Cracked Outflow Connecting Set
left, intended, right, showed, outflow
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
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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