FDAFDA · Food and drugs·Recall number Z-2320-2026
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Published June 17, 2026 · Recall initiated: April 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BERLIN HEART GMBH
- Distributor
- US Nationwide distribution in the states of MA, SC.
- Lot
- REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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