Device product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Z-1323-2013
Product summary
- Firm
- Heartware Inc
- Event
- Event 64390
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,544
- Official record key
device-enforcement:Z-1323-2013
Official wording
Reason: HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Code information: Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675
Distribution pattern: 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.
Derived failure modes
-
Unknown
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.