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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description HeartWare Ventricular Assist System For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
Recall Number Z-1813-2013
Classification Class II
Code Info US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
Product Distributed Qty 76 (US) and 82 (International)
Reason For Recall Potential to electrostatic discharged (ESD)

Event Detail

Event Id 65328
Product Type Devices
Status Ongoing
Recalling Firm HeartWare Inc
City Miami Lakes
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.