Recall Z-1107-2022— Heartware, Inc.

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, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Instructions For Use - FI HVAD¿ System Instructions For Use (FI) HVAD¿ System OUS Patient Manual (FI-Finnish) HVAD¿ System Emergency Responder Guide (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System OUS Instructions For Use (TR-Turkish). 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

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