FDA-Device2023-06-28Class II
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
Heartware, Inc.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
Affected count
19 units
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1993-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief