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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 11, 2015
Recall Status1 Open3, Classified
Recall Number Z-1726-2015
Recall Event ID 71242
PMA Number P100047 
Product Classification Ventricular (assisst) bypass - Product Code DSQ
Product HeartWare Ventricular Assist System (HVAD).
Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205.

Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage 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
Complaints with the HVAD Retraction of Pins within the driveline connector.
FDA Determined
Cause 2
Device Design
Action Urgent Medical Device Correction letters, dated APR2015, were sent to users. The letters identified the affected device, as well as the reason for the recall and risks involved. Users were asked to review and familiarize themselves with the notice and "Patient Communication." The notice should be forwarded to anyone within customers' organization that need to be aware. Customers are to identify their patients who are currently supported by the HVAD System and distribute the "Patient Communication" to them. A HeartWare representative can assist with that process is needed. Customers should continue to reinforce the messages in the notice with their patients. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of receipt of the notice. Questions or concerns should be directed to a local HeartWare representative. Clinical Support is also available at 1-888-494-6365.
Quantity in Commerce 3,747 currently in use
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 and Original Applicant = Medtronic