| Class 2 Device Recall HeartWare Ventricular Assist System (HVAD) | |
Date Initiated by Firm | April 29, 2015 |
Date Posted | June 10, 2015 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1751-2015 |
Recall Event ID |
71241 |
PMA Number | P100047 |
Product Classification |
Ventricular (assisst) bypass - Product Code DSQ
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Product | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. |
Code Information |
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101, 1102, 1104, 1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use. |
Recalling Firm/ Manufacturer |
HeartWare Inc 14400 Nw 60th Ave Miami Lakes FL 33014-2807
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For Additional Information Contact | 24-Hour Clinical Support 888-494-6365 |
Manufacturer Reason for Recall | Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. |
FDA Determined Cause 2 | Device Design |
Quantity in Commerce | 3,747 currently in use |
Distribution | 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,
Foreign: 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, Luxemburg,
Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore,
Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK, |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = DSQ
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