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U.S. Department of Health and Human Services

Class 1 Device Recall Heartware HVAD Pump Implant Kit

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 Class 1 Recall
Heartware HVAD Pump Implant Kit
see related information
Date Posted April 23, 2014
Recall Status1 Open
Recall Number Z-1471-2014
Recall Event ID 67466
Premarket Approval
PMA Number
P100047
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left 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 Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW11270 and HW20001 to HW 20296.
Recalling Firm/
Manufacturer
HeartWare Inc
14400 Nw 60th Ave
Miami Lakes, Florida 33014-2807
For Additional Information Contact Rozelle Smith
305-364-1590
Manufacturer Reason
for Recall
The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their hospitals and doctors on December 12, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. For already implanted patients, arrange a follow up visit at the earliest convenience to check patient's driveline connector. They were asked to sign and return the Acknowledgement Form to HeartWare. For questions, contact your HeartWare Representative or HeartWare Customer Service at 1-877-367-4823.
Quantity in Commerce 4,586
Distribution Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Africa, Spain, 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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