BEUDAMED
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    iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy.

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code DSQ·April 23, 2009

    HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered bye either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·September 1, 2010

    Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·October 19, 2007

    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.

    FDA Recall
    Terminated ·BERLIN HEART GMBH Wiesenweg 10 Berlin Germany·Product code DSQ·May 18, 2018

    HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

    FDA Recall
    Terminated ·Thoratec Corporation·Product code DSQ·March 30, 2017

    Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. Product is manufactured and distributed by Thoratec Corporation, Pleasant, CA. 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 transplantation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital.

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·October 24, 2008

    Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·September 24, 2004

    AB5000 Console Circulatory Support System Catalog Number: 0015-0000

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code DSQ·January 8, 2007

    HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    FDA Recall
    Terminated ·HeartWare Inc·Product code DSQ·April 16, 2014

    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.

    FDA Recall
    Terminated ·Thoratec Corporation·Product code DSQ·February 23, 2012

    HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

    FDA Recall
    Terminated ·Heartware, Inc.·Product code DSQ·June 8, 2016

    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable

    FDA Recall
    Terminated ·Jarvik Heart Inc·Product code DSQ·October 15, 2018

    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266

    FDA Recall
    Terminated ·Thoratec Corp.·Product code DSQ·March 30, 2019

    HeartMate II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

    FDA Recall
    Terminated ·Thoratec Corporation·Product code DSQ·March 30, 2017

    Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger.

    FDA Recall
    Terminated ·Heartware, Inc.·Product code DSQ·November 19, 2018

    BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code DSQ·August 19, 2003

    Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·August 25, 2006

    HeartMate Stroke Volume Limiter (SVL) Catalog # 1295

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·February 7, 2003

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    FDA Recall
    Terminated ·HeartWare Inc·Product code DSQ·May 16, 0013

    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.

    FDA Recall
    Terminated ·Thoratec Corporation·Product code DSQ·March 4, 2014