Recall Z-1105-2022— Heartware, Inc.

Name: FDA recall Z-1105-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-30

Class II · Ongoing

Class II FDA medical device recall by Heartware, Inc., initiated 2022-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0. Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system..

Recalling firm: Heartware, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-03-30
Firm location: Miami Lakes, FL, United States

Product description

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

Reason for recall

Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.