Z-0629-2019Class II

Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery...

Name: Z-0629-2019 Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery...
Creator: Jarvik Heart Inc
Published: 2018-10-15
License: https://open.fda.gov/license/

Jarvik Heart Inc / initiated 2018-10-15 / Terminated / root cause: design

FDA source

Jarvik Heart Inc began a recall of 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 on 2018-10-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0629-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-15
Posted: 2018-12-18
Terminated: 2020-05-01
Recalling firm: Jarvik Heart Inc
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
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Field Safety Notice letters dated 10/5/18 were distributed to customers.
Quantity in commerce: 274
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.
Product codes and lots: All systems/cables

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0629-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0629-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)