Class 1 Device Recall HeartWare Ventricular Assist System

• Date Initiated by Firm: February 03, 2017
• Create Date: April 27, 2017
• Recall Status: Open, Classified
• Recall Number: Z-1538-2017
• Recall Event ID: 76600
• PMA Number: P100047
• Product Classification: Ventricular (assisst) bypass - Product Code DSQ
• Product: HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated 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 Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
• Code Information: HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435 .
• Recalling Firm/ Manufacturer: Heartware; 14400 NW 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: 24-hr Clinical Support Personnel; 305-364-1575
• Manufacturer Reason for Recall: Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
• FDA Determined Cause: Software design
• Action: The firm will release a communication to their consignees stating the following: As a reminder, as with all HVAD Controllers, continue to reinforce the following with your patients and staff at all opportunities: " Patients should continue to have a backup HVAD Controller ready at all times in the event of a primary HVAD Controller failure. " Staff only: The driveline extension cable is to be used during the pre-implant test only. It is not intended to be used after the pump is implanted in the patient. Hospital and Clinician Actions (to be executed in the following order): 1) Review the enclosed notice and forms, and forward the notice to those individuals within your organization who need to be aware of its contents. 2) Complete, sign, and return the Acknowledgement Form to HeartWare within thirty (30) days of receipt of this letter. 4) Quarantine and replace affected HVAD Controllers, DC Adapters, Instructions for Use, Emergency Responder Guides and Patient Manuals in hospital inventory after training is complete. For every patient, quarantine and replace the following under clinical supervision in an environment where appropriate support equipment is readily available: - Primary and Backup HVAD Controller; - Affected DC Adapters; and - Patient Manual and Emergency Responder Guide. Clinicians are reminded not to perform an HVAD Controller exchange during an active electrical fault alarm as the HVAD Pump will be running a single stator. If an electrical fault is present, download patient log files and contact your HeartWare representative to resolve the electrical fault before executing the controller exchange. 5) Return all quarantined HVAD Controllers and DC Adapters to HeartWare. Your HeartWare representative will assist you with this process. 6) Completion Form. Once affected product in inventory has been identified and returned, complete and return the attached Completion Form to CON2.0@heartware.com or your HeartWare representative no late
• Quantity in Commerce: 8,343 US and 13,145 INTERNATIONAL
• Distribution: Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, , Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, UK, and Vietnam.
• 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