Heartware
Miami Lakes, FL
This page shows every FDA and USDA recall linked to Heartware. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
3
Total Recalls
2017
First Recall
2018
Most Recent
Heartware Medtronic HVAD System for cardiac use. Including the following parts:
(a) Controller / Controller...
May 21, 2018
· Device
Open, Classified
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit
Product Usage:
Is intended to repair th...
Mar 10, 2017
· Device
Open, Classified
HeartWare HVAD System Controller
The HeartWare Ventricular Assist System (VAS is indicated for use as a bridg...
Feb 3, 2017
· Device
Open, Classified