FDA Recall
Terminated
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
Recall: Z-0629-2019
·
Initiated October 15, 2018
Recall
- Recall Number
- Z-0629-2019
- Event Number
- 81709
- Firm
- Jarvik Heart Inc
- FEI Number
- 3003512469
- Product Code
- DSQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 15, 2018
- Terminated
- May 1, 2020
- Address
- 333 W 52nd St, Fl 15, New York, NY, 10019-6238
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
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.
Action
Urgent Field Safety Notice letters dated 10/5/18 were distributed to customers.
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.
Quantity
274