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.
Recall
- Recall Number
- Z-1228-2012
- Event Number
- 61268
- Firm
- Thoratec Corporation
- FEI Number
- 2916596
- Product Code
- DSQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 23, 2012
- Posted
- March 23, 2012
- Terminated
- November 8, 2012
- Address
- 6035 Stoneridge Dr, Pleasanton, CA, 94588-3270
Description
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.
A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified
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.
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.
3852 units in commerce