Class 2 Device Recall HeartWare Ventricular Assist System (HVAD)

• Date Initiated by Firm: April 29, 2015
• Date Posted: June 26, 2015
• Recall Status: Open, Classified
• Recall Number: Z-1917-2015
• Recall Event ID: 71240
• PMA Number: P100047
• Product Classification: Ventricular (assisst) bypass - Product Code DSQ
• Product: HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
• Code Information: Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
• Recalling Firm/ Manufacturer: HeartWare Inc; 14400 Nw 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: 24-Hours Clinical Support; 888-494-6365
• Manufacturer Reason for Recall: Complaints with the HVAD Abnormal Power Source Switching.
• FDA Determined Cause: Software design
• Action: HeartWare sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the enclosed Patient Communication and familiarize the contents, forward the notice to those individuals withing their organization who need to be aware of its contents, identify their patients currently supported by the HVAD System, distribute the Patient Communication to their patients via FedEX or some other reliable means of communication. Customers with questions were instructed to contact their HeartWare representative should they need any assistance with the process. Customers were asked to complete, sign, and return the Acknowledgement and Completion Form to HeartWare. Customers with quesitons were instructed to call 1-888-494-6365.
• Quantity in Commerce: 3,747 currently in use.
• Distribution: US including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = DSQ