FDAFDA · Food and drugs·Recall number Z-1813-2013
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Published August 7, 2013 · Recall initiated: May 16, 2013
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
Potential to electrostatic discharged (ESD)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- HeartWare Inc
- Distributor
- Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
- Lot
- US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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