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    Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

    FDA Recall
    Open, Classified ·Btt Health Gmbh Billerberg 7 Inning Germany·Product code BXB·August 1, 2024

    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: 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·May 28, 2021

    Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: 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
    Terminated ·Heartware, Inc.·Product code DSQ·August 28, 2018

    HeartWare HVAD System Battery Charger 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·January 23, 2020

    HeartWare HVAD System Battery Charger AC Adapter 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·January 23, 2020

    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

    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

    REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BTT·October 25, 2006

    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

    AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

    AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

    Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·April 17, 2014

    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    FDA Recall
    Open, Classified ·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·April 2, 2024

    Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW

    FDA Recall
    Open, Classified ·Vapotherm·Product code BTT·December 16, 2022

    Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211

    FDA Recall
    Terminated ·Fisher & Paykel Healthcare Inc·Product code BTT·December 20, 2005

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·June 5, 2014

    Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·June 5, 2014

    Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.

    FDA Recall
    Terminated ·Vyaire Medical·Product code BTT·November 29, 2014

    HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit

    FDA Recall
    Terminated ·TELEFLEX MEDICAL INC·Product code BTT·December 13, 2019