Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Recall #Z-1323-2013 — Class II — December 27, 2012
Product Description
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason for Recall
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Recalling Firm
Heartware Inc — Miami Lakes, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,544
Distribution
Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.
Code Information
Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated