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U.S. Department of Health and Human Services

Class 1 Device Recall HeartWare Ventricular Assist System

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  Class 1 Device Recall HeartWare Ventricular Assist System see related information
Date Initiated by Firm April 29, 2015
Date Posted June 08, 2015
Recall Status1 Open3, Classified
Recall Number Z-1698-2015
Recall Event ID 71164
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.

Product Usage:
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 Serial #: ALL HeartWare HVAD systems currently in use.
Recalling Firm/
HeartWare Inc
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact 24 Hours Clinical Support
Manufacturer Reason
for Recall
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
FDA Determined
Cause 2
Device Design
Action HeartWare sent an Urgent Medical Device Correction letter to customers on May 25, 2015. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Review the enclosed notice and Patient Communication. 2. Forward the notice to those individuals within their organization who need to be aware of its contents. 3. Identify the patients currently supported by the HVAD System. 4. Distribute the "Patient Communication" to their patients directly via FedEx or some other reliable means of communication. 5. Continue to reinforce the messages set forth in the notice with their patients during their regularly scheduled appointments. 6. Complete, sign and return the Acknowledgement and Completion Form to HeartWare within 30 days of receipt of this letter. For questions contact your local HeartWare representative or the 24-Hour Clinical Support personnel at 1-888-494-6365.
Quantity in Commerce 3,747 currently implanted worldwide
Distribution Worldwide Distribution - US Nationwide in 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, VA and 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 and Original Applicant = Medtronic