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U.S. Department of Health and Human Services

Class 1 Device Recall HeartMate II Left Ventricular Assist System

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  Class 1 Device Recall HeartMate II Left Ventricular Assist System see related information
Date Initiated by Firm February 23, 2012
Date Posting Updated March 23, 2012
Recall Status1 Terminated 3 on November 08, 2012
Recall Number Z-1228-2012
Recall Event ID 61268
PMA Number P060040 P060040S004 P060040S005 
Product Classification Ventricular (assisst) bypass - Product Code DSQ
Product HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief.
The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in turn is a component of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM II LVAS Sealed Outflow Graft Bend Relief is provided as a stand-along product.

Thoratec Corporation
6035 Stoneridge Drive
Pleasanton, CA 94588.

Product Usage:
The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to Cardiac Transplanation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital. The outflow of the HM II LVAS blood pump is connected to the aorta with a flexible vascular graft. The outflow graft is provided with a bend relief, a three or four in long tube of reinforced ePTFE surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft.

Code Information Sealed Outflow Graft: Catalog number 103393, all lot numbers;, Sealed Outflow Short Bend Relief; Catalog number 104692, all lot numbers;, Catalog number 104911, HM II LVAS Implant Kit (with sealed grafts) [US labeling] (contains catalog number 103393); all serial numbers;, Catalog number 104912, HM II LVAS Implant Kit (with sealed grafts) [CE Mark labeling], contains catalog no. 103393); all serial numbers:.
Recalling Firm/
Thoratec Corporation
6035 Stoneridge Dr
Pleasanton CA 94588-3270
For Additional Information Contact Donald A. Middlebrook
925-847-8600 Ext. 1237
Manufacturer Reason
for Recall
A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified
FDA Determined
Cause 2
Device Design
Action Thoractec Corporation sent an Urgent Medical Device Correction letter on February 23, 2012 via overnight courier and e-mail to all affected consignees. The Urgent Medical Device Correction notification letters identify the affected products, description of the problem with illustrations, symptoms of problem and immediate actions to taken. All users are asked to review the attached labeling, including new caution statements and share with all surgical personnel. Consignees are instructed to completed and returned the Acknowledgement Form indicating that the information was received and understood. Additionally, an update concerning the Worldwide Medical Device Correction Notification is enclosed with each letter. Questions should be directed to Thoratec Regulatory Affairs at 925-847-8571.
Quantity in Commerce 3852 units in commerce
Distribution Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Denmark, Germany, Greece, France, Hong Kong, Kuwait, Ireland, Israel, Italy, Lebanon, Liechtenstein, Lithuania, Luxembourg, Malaysia, Netherlands, Turkey, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand 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 = THORATEC CORP.