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U.S. Department of Health and Human Services

Class 2 Device Recall HeartMate 12 volt sealed lead acid Battery Clips

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 Class 2 Recall
HeartMate 12 volt sealed lead acid Battery Clips
see related information
Date Posted November 24, 2009
Recall Status1 Terminated on April 18, 2011
Recall Number Z-0422-2010
Recall Event ID 53561
Premarket Approval
PMA Numbers
P060040 P920014
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support.
Code Information Lot numbers are visible on the clips: 458560206, 581080207, 581080507, 34331720107, 34404690108, 34532990109, 343317201407, 34331720207,34331720507, 34404690208, 34404690308, 34404690408, 34432810108, 34450070108, 34477720108, 34570570109, 34577730109, 34331720307.
Recalling Firm/
Manufacturer
Thoratec Corp
6035 Stoneridge Drive
Pleasanton, California 94588
Manufacturer Reason
for Recall
Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Firm has issued a notification letter to consignees, dated October 14, 2009 asking them to return proof of receipt, and to remove all affected unused devices from stock, and asking ongoing patients to return to hospitals for inspection, replacement if needed, and retraining on the process of switching power sources and safely switching to a back-up system controller. Contact Thoratec Customer Services at 1-800-456-1477 for any questions or concerns about this issue.
Quantity in Commerce 8,194 battery clips
Distribution Worldwide - USA- AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the District Columbia. Internationally to Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Lithuania, Luxembourg, Monaco, Netherlands, Singapore, South Africa, Sweden, Switzerland, Taiwan and the UK.
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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