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U.S. Department of Health and Human Services

Class 2 Device Recall Ventricular Assist Device

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  Class 2 Device Recall Ventricular Assist Device see related information
Date Initiated by Firm May 16, 0013
Date Posted July 29, 2013
Recall Status1 Terminated 3 on August 05, 2019
Recall Number Z-1813-2013
Recall Event ID 65328
PMA Number P100047 
Product Classification Ventricular (assisst) bypass - Product Code DSQ
Product Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Code Information US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
Recalling Firm/
Manufacturer		 HeartWare Inc
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact
305-364-1575
Manufacturer Reason
for Recall		 Potential to electrostatic discharged (ESD)
FDA Determined
Cause 2		 Device Design
Action HeartWare sent an Urgent Medical Device Correction Safety Notification letter on May 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to educate their patients about the HeartWare Controller and instructions for equipment handling stated in the IFU and recognized practices to avoid electrostatic discharge. The direct accounts were also told to scan and return the signed Acknowledgment Form via fax to 305-364-2665 or e-mail to quality@heartwareinc.com. Customers with questions were instructed to contact their HeartWare Representative or HeartWare Customers Service. For questions regarding this recall call 305-364-1575.
Quantity in Commerce 76 (US) and 82 (International)
Distribution Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
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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