Recall Z-0629-2019— Jarvik Heart Inc
Class II · Terminated
Class II FDA medical device recall by Jarvik Heart Inc, initiated 2018-10-15, terminated 2020-05-01. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Jarvik Heart Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-15
- Terminated
- 2020-05-01
- Firm location
- New York, NY, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.