Reported Dec 26, 2018 · Terminated

Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204…

Jarvik Heart Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Jarvik Heart Inc · 333 W 52nd St Fl 15 · New York, NY · 10019-6238

Is this the product you have?

  • 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
Lot codes and dates
  • All systems/cables
Amount recalled
274

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 1, 2020 · Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.