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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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