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U.S. Department of Health and Human Services

Class 2 Device Recall HVAD Pump Implant Kit

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 Class 2 Recall
HVAD Pump Implant Kit
see related information
Date Posted May 14, 2013
Recall Status1 Terminated on July 09, 2013
Recall Number Z-1323-2013
Recall Event ID 64390
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 Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675
Recalling Firm/
Manufacturer
Heartware Inc
14000 NW 57th Ct
Miami Lakes, Florida 33014-3105
For Additional Information Contact Jose E. Cabrera
305-818-4107
Manufacturer Reason
for Recall
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
FDA Determined
Cause 2
DESIGN: Device Design
Action HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their customers on February 7, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. They were asked to sign and return the acknowledgement form to HeartWare. For questions contact your HeartWare representative or Customer Service at 1-877-367-4823.
Quantity in Commerce 3,544
Distribution Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.
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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