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 CableJHI-202 Lithium-ion Battery CableJHI-204 Extensions CableJHI-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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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