Recall Z-0629-2019 ยท DSQ Ventricular (Assist) Bypass
Jarvik Heart Inc
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
| Date | Oct 15, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Urgent Field Safety Notice letters dated 10/5/18 were distributed to customers. |
| Quantity | 274 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.