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U.S. Department of Health and Human Services

Class 1 Device Recall HeartMate II System Controller

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 Class 1 Recall
HeartMate II System Controller
see related information
Date Posted March 21, 2014
Recall Status1 Open
Recall Number Z-1228-2014
Recall Event ID 67639
Premarket Approval
PMA Number
P060040
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.
Code Information Catalog number 106762 (NAm) 106017 - EU all serial numbers
Recalling Firm/
Manufacturer
Thoratec Corporation
6035 Stoneridge Dr
Pleasanton, California 94588-3270
For Additional Information Contact Donald A. Middlebrook
925-847-8600
Manufacturer Reason
for Recall
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
FDA Determined
Cause 2
DESIGN: Device Design
Action Thoratec sent an Urgent Medical Device Correction letter dated March 4, 2014 to all affected customers. The letter was sent via e-mail. All distributors outside of the USA and Canada to whom affected product has been distributed have been notified of this field correction notice and have been provided copies of the Customer Letter to forward to their customers. The letter identified the affected product , problem and actions to be taken. Customers were requested to complete and sign the attached Acknowledgement Form and return it to Thoratec via fax (925-847-8571) or e-mail a scanned copy to customer.service@thoratec.com. For questions call 1-800-528-2577.
Quantity in Commerce 4120
Distribution Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, 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 = THORATEC CORP.
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