HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB ...
FDA Recall #Z-1993-2023 — Class II — May 16, 2023
Product Description
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.
Recalling Firm
Heartware, Inc. — Miami Lakes, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
19 units
Distribution
Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
Code Information
a) Model Number 1521US, GTIN 00888707009256, Serial/Lot Numbers: MON500010, MON500012, MON500016, MON500028, MON500026, MON500005, MON500006, MON500007. b) Model Number 1521GB, GTIN 00888707006521, Serial/Lot Numbers: MON400039, MON400050, MON400051, MON400052, MON400053, MON400054, MON400061. c) Model Number 1521IL, GTIN 00888707010108, Serial/Lot Number: MON400017. d) Model Number 1521DE, GTIN 00888707010085, Serial/Lot Numbers: MON400045, MON400021, MON400013.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.