Jarvik Heart Inc: Medical Device Recall in 2018 - (Recall #: Z-0629-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 15, 2018

Date Posted: December 26, 2018

Recall Number: Z-0629-2019

Event ID: 81709

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.

Status: Terminated

Product Quantity: 274

Code Information:

All systems/cables

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated