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U.S. Department of Health and Human Services

Class 1 Device Recall Heart Mate II Pocket Controllers removed from packaging

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 Class 1 Recall
Heart Mate II Pocket Controllers removed from packaging
see related information
Date Posted March 21, 2014
Recall Status1 Open
Recall Number Z-1230-2014
Recall Event ID 67639
Premarket Approval
PMA Number
P060040
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product Heart Mate II Pocket Controllers removed from packaging 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.
Code Information Catalog number 105109 (found on side of unit) 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 7436 in total
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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