Device 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
Z-0629-2019
Product summary
- Firm
- Jarvik Heart Inc
- Event
- Event 81709
- Status
- Terminated
- Classification
- Class II
- Quantity
- 274
- Official record key
device-enforcement:Z-0629-2019
Official wording
Reason: 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.
Code information: All systems/cables
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.