HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1

FDA device recall Z-1993-2023 · posted 2023-06-22 · Open, Classified

Recall details

Recalling firm

Heartware, Inc.

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.

Action taken

Medtronic Mechanical Circulatory Support issued an URGENT MEDICAL DEVICE COMMUNICATION notice to it consignees on 05/16/2023 by email. The notice explained that 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. Medtronic is working on an update to the Autologs web portal to resolve the issue. Until the update is complete, logfiles can be sent to dl.mcsclinicalengineering@medtronic.com for report generation. Please note in the email that you have received a logfile upload error and are requesting a logfile report. On about 09/20/2023, a formal Urgent Medical Device Communication notification was sent to Healthcare Professionals (HCPs) informing them of the resolution of the autologs web portal issue previously communicated. Consignees are asked to confirm receipt of the letter and that they have acknowledged the actions to be taken.

Root cause

Software change control

Status

Open, Classified

Product code

DSQ

Quantity affected

19 units

Distribution

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

Date initiated

2023-05-16

Date posted

2023-06-22

Location

Miami Lakes, FL