FDAOctober 15, 2018device
Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for the male connectors on external cables to become damaged. This could include a detached male connector housing, misaligned connector, cracked connector housing, and bent pins.
What to do
FDA enforcement status: Terminated
Brands named
jarvik heartjarvik
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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