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U.S. Department of Health and Human Services

Class 2 Device Recall Jarvik 2000 Ventricular Assist System

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  Class 2 Device Recall Jarvik 2000 Ventricular Assist System see related information
Date Initiated by Firm October 15, 2018
Create Date December 18, 2018
Recall Status1 Terminated 3 on May 01, 2020
Recall Number Z-0629-2019
Recall Event ID 81709
Product Classification Ventricular (assist) bypass - Product Code DSQ
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
Code Information All systems/cables
Recalling Firm/
Manufacturer
Jarvik Heart Inc
333 W 52nd St Fl 15
New York NY 10019-6238
For Additional Information Contact Kamal Gahdhi
212-397-3911
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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