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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·Heartware, Inc.·October 10, 2018
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
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
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
Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.
FDA Recall
Terminated
·Teleflex Medical·Product code BTT·March 19, 2010
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
FDA Recall
Terminated
·Vapotherm, Inc.·Product code BTT·August 13, 2014
HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709. Use to add water vapor to a dry medical gas for administration to a patient.
FDA Recall
Terminated
·Teleflex Medical·Product code BTT·June 6, 2011
Adult AirLife dual-limb, dual-heat circuit (Model AH280) 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
Concha IV Plus Heated Humidifier
FDA Recall
Terminated
·Hudson Respiratory Care Inc·Product code BTT·April 20, 2004
Vapotherm" Respiratory Gas Humidifier, Model 2000i, labeled in part ***Vapotherm Inc., Annapolis, MD 21401***.
FDA Recall
Terminated
·Vapotherm, Inc.·Product code BTT·October 13, 2005