FDA Device recall Z-0629-2019
Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JH…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JH… by Jarvik Heart, citing 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 ho….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0629-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-15 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Jarvik Heart |
| Distribution | FL, NY, UT |
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
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.
Identifiers
| code_info | All systems/cables |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0629-2019%22
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