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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Device Recall St. Jude Medical CPS Slitter Cardiovascular Devices St Jude Medical CRMD 2 United States USFDA
Device Recall St. Jude Medical CPS Valve Bypass Tool (VBT) Cardiovascular Devices St Jude Medical CRMD 2 United States USFDA
Device Recall St. Jude Medical CPS Direct SL Cardiovascular Devices St Jude Medical CRMD 2 United States USFDA
Device Recall St. Jude Medical CPS Aim Cardiovascular Devices St Jude Medical CRMD 2 United States USFDA
Device Recall St. Jude Medical CPS Implant Kit Cardiovascular Devices St Jude Medical CRMD 2 United States USFDA
"Left Ventricular Electrodes for QuickSite® CRT", Models 1056T and 1058T and "Left Ventricular Electrodes for QuickFlex® TRC", Models 1156T and 1158T manufactured by St. Jude Medical CRMD, USA. St. Jude Medical CRMD Spain AEMPSVFOI
Implantable pulse generators: "Eon", Model 65-3716 and "Eon Mini", Model 65-3788 for stimulation of the spinal cord and "Brio", Model 65-6788 for deep brain stimulation, manufactured by St. Jude Medical USA St. Jude Medical Spain AEMPSVFOI
Implantable pulse generators: "Eon MiniTM", Model 65-3788 for stimulation of the spinal cord and "BrioTM", Model 65-6788 for deep brain stimulation. Serial numbers manufactured before September 2010 by St. Jude Medical USA St. Jude Medical Spain AEMPSVFOI
Implantable Pulse Generator (GPI) "Eon MiniTM" Model 65-3788 for stimulation of the spinal cord, Eon Min Model 3721 Charger and Eon Mini Model 3719 Charger Accessory, manufactured by St. Jude Medical USA St. Jude Medical Spain AEMPSVFOI
Fortified ™ Implantable Cardioverter Defibrillators, FortifyAssura ™, QuadraAssura ™, QuadraAssura MP ™, Unify ™, UnifyAssura ™ and UnifyQuadra ™, manufactured by St. Jude Medical, USA, between January 2010 and May 2015. St. Jude Medical Spain AEMPSVFOI
8-Channel Lead for the St. Jude Medical Infinity™ DBS (Deep Brain Stimulation) System St. Jude Medical Inc. Saudi Arabia SFDA
1. Merlin PCS 3650 Software Upgrade Kit , 2. Merlin@home Transmitter Software, 3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™), St. Jude Medical St Jude Medical (Singapore) Pte Ltd Singapore HSA
Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical St. Jude Medical (Singapore) Pte Ltd Singapore HSA
St. Jude Medical AGILIS Steerable Catheter Introducer Cardiovascular Devices St. Jude Medical / Daig Division 2 United States USFDA
St. Jude Medical FASTCATH Hemostasis Introducer Cardiovascular Devices St. Jude Medical 2 United States USFDA
St. Jude Medical FASTCATH Hemostasis Introducer Cardiovascular Devices St. Jude Medical 2 United States USFDA
Device Recall Heritage Labs St. Jude Childhood Cancer Study kit Hematology and Pathology Devices Heritage Labs International LLC 2 United States USFDA
All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ implantable cardioverter defibrillators (ICDs) and Assurity™ and Allure™ pacemakers when used with Merlin@home™ RF Remote Monitoring Transmitter Model EX1150. St. Jude Medical United Kingdom MHRA
St. Jude Medical Infinity™ DBS System (8-Channel) St. Jude Medical (Abbott) United Kingdom MHRA
Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator Cardiovascular Devices Osypka Medical Inc 3 United States USFDA
Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA Cardiovascular Devices St. Jude Medical / Daig Division 2 United States USFDA
All models of RF enabled St. Jude Medical Ellipse™ and other devices St. Jude Medical Ireland HPRA
Implantable Cardioverter Defibrillator: St. Jude Medical Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™ Cardiovascular Devices St. Jude Medical, Inc. Ireland HPRA
St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0 Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families St Jude Medical Australia Pty Ltd Australia DHTGA
St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs) Cardiovascular Devices St Jude Medical Australia Pty Ltd Australia DHTGA