FDA Enforcement
Class II
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
·
Reported December 26, 2018
Enforcement
- Recall Number
- Z-0629-2019
- Event ID
- 81709
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Jarvik Heart Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 26, 2018
- Initiation Date
- October 15, 2018
- Classification Date
- December 18, 2018
- Termination Date
- May 1, 2020
- Address
- 333 W 52nd St Fl 15, New York, NY, 10019-6238, United States
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.
Code Info
All systems/cables
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