FDAHealthApril 24, 2026
BERLIN HEART GMBH — EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
⚠️ Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 24, 2026
US Nationwide distribution in the states of MA, SC.
What's affected?
- Product
- EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
- Brand
- BERLIN HEART GMBH
- Lot code
- REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Additional details
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3.
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