FDA-Device2018-12-26Class II
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
Jarvik Heart Inc
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.
Sold states
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.
Affected count
274
Manufactured in
333 W 52nd St Fl 15, New York, NY, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0629-2019Don't want to check this manually?
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