Brand

Heartware, Inc. Recalls

53 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Heartware, Inc..

53Total Recalls
29Critical
436,005Units Affected
Oct 31, 2023Most Recent
All Recalls

Every Heartware, Inc. Recall

Sorted by most recent. Click any recall for full details.

53 recalls
CriticalFDA
Heartware Inc
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients ...
Cardiac Devices·4,845 affected·Jan 16, 2015
High RiskFDA
Heartware Inc
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantati...
Medical Implants·32,349 affected·Apr 16, 2014
CriticalFDA
Heartware Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use...
Medical Implants·4,586 affected·Dec 6, 2013
High RiskFDA
Heartware Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Medical Implants·76 affected·May 16, 2013
High RiskFDA
Heartware Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Medical Implants·3,544 affected·Dec 27, 2012