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U.S. Department of Health and Human Services

Class 1 Device Recall HeartWare Ventricular Assist System

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  Class 1 Device Recall HeartWare Ventricular Assist System see related information
Date Initiated by Firm January 16, 2015
Date Posted February 25, 2015
Recall Status1 Terminated 3 on February 05, 2020
Recall Number Z-1131-2015
Recall Event ID 70340
PMA Number P100047 
Product Classification Ventricular (assisst) bypass - Product Code DSQ
Product HeartWare Ventricular Assist System (HeartWare Controller)

Product Usage:
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 System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Code Information Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472
Recalling Firm/
Manufacturer		 HeartWare Inc
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact HeartWare Representative
305-364-1575
Manufacturer Reason
for Recall		 The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
FDA Determined
Cause 2		 Device Design
Action HeartWare sent an URGENT MEDICAL DEVICE RECALL dated January 16, 2015 asking clinicians to quarantine the affected controllers and complete and return the acknowledgement form. HeartWare also asks clinicians to identify patients with affected controllers and review the applicable risks with the patient and as soon as reasonably possible if medically advisable, exchange the affected controller under medical supervision with a new controller. HeartWare also asks that for each patient using an affected controller as their backup to contact the patient and arrange to have the backup controller replaced with a new controller. Lastly, HeartWare asks the firm to complete the patient tracking form and return all quarantined controllers to HeartWare along with the completion form. Should you have any questions or concerns, please contact your local HeartWare representative. Our 24-Hour Clinical Support personnel are also available at 1-888-494-6365.
Quantity in Commerce 4,845
Distribution Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
Total Product Life Cycle TPLC Device Report
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.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic
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