Jarvik Heart Inc
Jarvik Heart Inc appears in FDA public data with 1 recall, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0629-2019, Class II) was initiated on October 15, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0629-2019 | Class II | Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Bat | October 15, 2018 |