FDAFDA · Food and drugs·Recall number Z-1607-2014
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.
Published May 21, 2014 · Recall initiated: April 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- HeartWare Inc
- Distributor
- 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.
- Lot
- Catalog# USA:1650 // OUS: 1650, 1650-DE All HeartWare Battery Serial Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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