Heartware, Inc. recalls HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor…

Recall date

May 16, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1993-2023

FDA classification

Class II

Brand / firm

Heartware, Inc.

Sold / distributed

Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.

Why it was recalled

Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech