HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reported: May 21, 2014 Initiated: April 16, 2014 #Z-1607-2014
Product Description
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for Recall
Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
Details
- Recalling Firm
- HeartWare Inc
- Units Affected
- 32,349
- Distribution
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.. Recalled by HeartWare Inc. Units affected: 32,349.
Why was this product recalled? ▼
Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2014. Severity: Moderate. Recall number: Z-1607-2014.
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