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U.S. Department of Health and Human Services

Class 2 Device Recall Ventricular Assist Device

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 Class 2 Recall
Ventricular Assist Device
see related information
Date Posted July 29, 2013
Recall Status1 Open
Recall Number Z-1813-2013
Recall Event ID 65328
Premarket Approval
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, Florida 33014-2807
Manufacturer Reason
for Recall
Potential to electrostatic discharged (ESD)
FDA Determined
Cause 2
DESIGN: 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 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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