Class 2 Device Recall Jarvik 2000 Ventricular Assist System

• Date Initiated by Firm: October 15, 2018
• Create Date: December 18, 2018
• Recall Status: Terminated 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: 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.