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U.S. Department of Health and Human Services

Class 2 Device Recall HeartWare Ventricular Assist System

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 Class 2 Recall
HeartWare Ventricular Assist System
see related information
Date Posted May 14, 2014
Recall Status1 Open
Recall Number Z-1607-2014
Recall Event ID 67684
Premarket Approval
PMA Number
P100047
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Code Information Catalog# USA:1650 // OUS: 1650, 1650-DE All HeartWare Battery Serial Numbers
Recalling Firm/
Manufacturer
HeartWare Inc
14400 Nw 60th Ave
Miami Lakes, Florida 33014-2807
Manufacturer Reason
for Recall
Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action HeartWare sent an Urgent Medical Device Correction letter dated April 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to familiarize themselves with the letter and review their Patient Manual about proper power management. Discuss with their VAD Coordinator any questions they may have about the HeartWare System or the letter. Always keep two (2) power sources connected to your controller; never leave your controller connected to only one (1) power source except while briefly switching to another power source. " Review the recommended practices for power management provided later in this letter. If a battery shows any of the abnormal battery behaviors described, stop using that battery and contact your VAD Coordinator immediately to replace it. Customers were instructed to confirm that they have received and understood the information. Sign and return the enclosed Confirmation form as soon as they can to HeartWare in the prepaid self-addressed envelope or by fax to 1-305-364-2665. For questions customers were instructed to contact their doctor or VAD coordinator. For questions regarding this recall call 305-364-1575.
Quantity in Commerce 32,349
Distribution Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = DSQ and Applicant = HEARTWARE, INC.
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