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HeartWare, Inc recalls HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX.
Recalled October 19, 2016 · FDA recall Z-0006-2017 · HeartWare
Hazard
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults. · FDA Class I
Units
344 pumps
Sold at
Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.
Description
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Product
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Manufacturer(s)
HeartWare, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →