Jarvik 2000 Ventricular Assist System external components: JHI-212 Y… — Class II medical device recall Z-0629-2019
Terminated recall by Jarvik Heart Inc, reported 2018-12-26, distributed in FL, NY, UT. There is a potential for the male connectors on external cables to become damaged. This could include a detach
| Recall number | Z-0629-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jarvik Heart Inc, New York, NY, United States |
| Recall initiated | 2018-10-15 |
| Classified | 2018-12-18 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-05-01 |
| Distributed | FL, NY, UT |
| Countries outside the US | CZ, FR, HR, HU, IN, IT, JP |
| Quantity | 274 |
| Reason classes | packaging, device malfunction |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0629-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.