FDAFDA · Food and drugs·Recall number Z-1751-2015
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Published June 17, 2015 · Recall initiated: April 29, 2015
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- HeartWare Inc
- Distributor
- AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA, Foreign: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK,
- Lot
- Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101, 1102, 1104, 1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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