Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0629-2019 · Posted None

Recalling FirmJarvik Heart Inc
Recall StatusTerminated
Product CodeDSQ
Date Initiated2018-10-15
Date Terminated2020-05-01
Product Quantity274

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.

Firm Action

Urgent Field Safety Notice letters dated 10/5/18 were distributed to customers.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑