FDA Recall Open, Classified

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

Recall: Z-1993-2023 · Initiated May 16, 2023

Recall

Recall Number: Z-1993-2023
Event Number: 92350
Firm: Heartware, Inc.
FEI Number: 3007042319
Product Code: DSQ
Status: Open, Classified
Root Cause: Software change control
Initiated: May 16, 2023
Posted: June 22, 2023
Address: 14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

Description

Reason

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

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 [email protected] 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.

Distribution

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

Quantity

19 units