Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Heartware, Inc. HeartWare Ventricular Assist Device System [a) Monitor 1521 US Explore Tech; GTIN 00888707009256; Serial/Lot Numbers: MON500010, MON500012, MON500016, MON500028, MON500026; b) MONITOR 1521GB EXPLORE TECH; GTIN 00888707006521; Serial/Lot Numbers: MON400039, MON400050, MON400051, MON400052, MON400053, MON400054] [HKMD No.: 180485].
According to the FDA, 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.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92350
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Jun 2023