FDA recall Z-1993-2023

Heartware, Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2023-05-16
Report date: 2023-06-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1993-2023