Device recall
Z-0629-2019: Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable…
FDA device recall · Class II · Jarvik Heart Inc
Key facts
| Recall number (Z-number) | Z-0629-2019 |
|---|---|
| Recall event | 81709 |
| 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 |
| Product code | DSQ |
| Recalling firm | Jarvik Heart Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 1, 2020 |
| FEI number | 3003512469 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database