Class 2 Device Recall Ventricular Assist Device

• Date Initiated by Firm: May 16, 0013
• Date Posted: July 29, 2013
• Recall Status: Terminated on August 05, 2019
• Recall Number: Z-1813-2013
• Recall Event ID: 65328
• PMA Number: P100047
• Product Classification: Ventricular (assisst) bypass - Product Code DSQ
• Product: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
• Code Information: US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
• Recalling Firm/ Manufacturer: HeartWare Inc; 14400 Nw 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: 305-364-1575
• Manufacturer Reason for Recall: Potential to electrostatic discharged (ESD)
• FDA Determined Cause: Device Design
• Action: HeartWare sent an Urgent Medical Device Correction Safety Notification letter on May 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to educate their patients about the HeartWare Controller and instructions for equipment handling stated in the IFU and recognized practices to avoid electrostatic discharge. The direct accounts were also told to scan and return the signed Acknowledgment Form via fax to 305-364-2665 or e-mail to quality@heartwareinc.com. Customers with questions were instructed to contact their HeartWare Representative or HeartWare Customers Service. For questions regarding this recall call 305-364-1575.
• Quantity in Commerce: 76 (US) and 82 (International)
• Distribution: 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.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = DSQ