BEUDAMED
    63 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

    FDA Recall
    Open, Classified ·HeartWare Inc·Product code DSQ·April 29, 2015

    HeartWare HVAD Pump Kit, REF MCS1705PU

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    HeartWare HVAD Pump Kit, REF 1104

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·May 16, 2023

    Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·April 3, 2020

    Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·February 26, 2021

    Medtronic HVAD Pump Implant Kits

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·August 6, 2021

    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model Number: 1440 HVAD DATA CABLE 1575- MONITOR, Model Number: 1575 HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE HeartWare Patient Pack, Model Number: 1475 HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·February 26, 2021

    HeartWare HVAD Pump Implant Kit, REF 1104

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·June 3, 2021

    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

    FDA Recall
    Open, Classified ·HeartWare Inc·Product code DSQ·April 29, 2015

    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

    FDA Recall
    Open, Classified ·HeartWare Inc·Product code DSQ·April 29, 2015

    HeartWare HVAD Pump Kit, REF 1104CA-CLIN

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·October 31, 2023

    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    FDA Recall
    Open, Classified ·HeartWare, Inc·Product code DSQ·August 17, 2016

    HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022

    HeartWare HVAD Pump Kit, REF 1205

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·October 31, 2023

    HeartWare Model 1101

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Instructions For Use (FI) HVAD System Instructions For Use (FI) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Instructions For Use - FI HVAD System Instructions For Use (FI) HVAD System OUS Patient Manual (FI-Finnish) HVAD System Emergency Responder Guide (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System OUS Instructions For Use (TR-Turkish)

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022