HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reported: March 4, 2015 Initiated: January 16, 2015 #Z-1131-2015
Product Description
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for Recall
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Details
- Recalling Firm
- HeartWare Inc
- Units Affected
- 4,845
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.. Recalled by HeartWare Inc. Units affected: 4,845.
Why was this product recalled? ▼
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2015. Severity: Critical. Recall number: Z-1131-2015.
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