FDAFDA · Food and drugs·Recall number Z-1323-2013
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Published May 22, 2013 · Recall initiated: December 27, 2012
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
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Heartware Inc
- Distributor
- 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.
- Lot
- Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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