FDAMay 18, 2018device
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively repor...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.
What to do
FDA enforcement status: Terminated
Brands named
berlin heartberlin
UPCs
042600900401020426009004015704260090040119042600900401260426009004001004260090040027
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x012026-04-24
- FDAICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; 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 DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators2023-05-10
- FDAICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators2023-05-10
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