HeartWare Inc recalls Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, a

Recalled April 30, 2014 · FDA recall Z-1471-2014 · HeartWare

Hazard

The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector. · FDA Class I

Units

4,586

Sold at

Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey and United Kingdom.

Description

The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.

Product

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is 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 →