New York, NY, United States
Jarvik Heart Inc recalls
1 recall recorded since 2018, most recently on 15 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 15 October 2018
- Terminated
- 1 May 2020
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0629-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.