Reported Jun 28, 2023 · Ongoing
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor…
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- 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
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 00888707009256Model Number 1521US, , Serial/Lot Numbers: MON500010, MON500012, MON500016, MON500028, MON500026, MON500005, MON500006, MON500007. 00888707006521Model Number 1521GB, , Serial/Lot Numbers: MON400039, MON400050, MON400051, MON400052, MON400053, MON400054, MON400061. 00888707010108Model Number 1521IL, , Serial/Lot Number: MON400017. 00888707010085Model Number 1521DE, , Serial/Lot Numbers: MON400045, MON400021, MON400013. - Amount recalled
- 19 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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