Class 1 Device Recall HeartWare Ventricular Assist System

• Date Initiated by Firm: April 29, 2015
• Date Posted: June 13, 2015
• Recall Status: Open, Classified
• Recall Number: Z-1731-2015
• Recall Event ID: 71239
• PMA Number: P100047
• Product Classification: Ventricular (assisst) bypass - Product Code DSQ
• Product: HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP 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.
• Code Information: 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 Internal Controller Alarm Battery failures.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Correction letters were sent to customers. The letter identified the affected product, as well as the reason for the recall and risks involved. HeartWare requests that customers review and familiarize themselves with the letter and "Patient Communication," and ensure that all necessary individuals are aware. Patients currently being supported by the device should be identified and given the "Patient Communication." A HeartWare representative can provide assistance with that process if needed. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of the receipt of the letter. Customers can contact their local HeartWare representative with questions or concerns. Clinical Support personnel are also available at 1-888-494-6365.
• Quantity in Commerce: 3,747 curently implanted
• Distribution: Worldwide Distribution -- US, including the states of 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, and VA; and, the countries of 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, Luxembourg, 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