| Class 1 Device Recall Heartware HVAD Pump Implant Kit | |
Date Initiated by Firm | December 06, 2013 |
Date Posted | April 23, 2014 |
Recall Status1 |
Terminated 3 on November 03, 2016 |
Recall Number | Z-1471-2014 |
Recall Event ID |
67466 |
PMA Number | P100047 |
Product Classification |
Ventricular (assisst) bypass - Product Code DSQ
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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 FL 33014-2807
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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 | 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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = DSQ
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