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Jarvik Heart Inc recalls Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204
Recalled December 26, 2018 · FDA recall Z-0629-2019 · Jarvik Heart
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. · FDA Class II
Units
274
Sold at
Products were distributed to the following US states: FL, NY, and UT. Products were distributed to the following foreign countries: Croatia, Czech Republic, France, Hungary, India, Italy, and Japan.
Description
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.
Product
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
Manufacturer(s)
Jarvik Heart Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →