The Recall Desk
HighFDA (Devices)·Z-0629-2019·Announced 2018-12-26

Jarvik 2000 Ventricular Assist System External Cables Recalled for Connector Damage

Jarvik Heart Inc is recalling 274 external cable components for the Jarvik 2000 Ventricular Assist System due to potential damage to male connectors.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a life-sustaining medical device where connector damage poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Jarvik Heart Inc is recalling 274 units of external cable components for the Jarvik 2000 Ventricular Assist System. The affected products include the JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, and JHI-201 Pedestal Cable.

The recall is due to a potential for the male connectors on these external cables to become damaged. This damage could include a detached male connector housing, misaligned connector, cracked connector housing, and bent pins.

The products were distributed to the US states of Florida, New York, and Utah, as well as to Croatia, Czech Republic, France, Hungary, India, Italy, and Japan. The source text does not specify instructions for consumers or patients regarding the next steps to take.

The recalled product

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
Manufacturer
Jarvik Heart Inc
Category
Medical Device — Ventricular Assist System
Hazard
Affected units
274

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All systems/cables

Distribution

Distributed in 3 states:

Related recalls

Same hazard · connector damage

See all →