FDAApril 24, 2026device
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Ongoing
Brands named
berlin heartberlin
UPCs
0426009004010204260090040126
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators2023-05-10
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