List view Cards view
Name Date Date initiated Country Source
Recall of VALITUDE CRT-P 2017-12-20 Australia DHTGA
Recall of Brio Charging System Model 6721 (used with Deep Brain Stimulator, Brio IPG Model 65-6788) 2015-09-15 Australia DHTGA
Recall of Optisure Dual Coil Defibrillation Leads(Lead, defibrillator/pacemaker, implantable 2015-11-06 Australia DHTGA
Recall of 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 2014-01-23 Australia DHTGA
Recall of Eon Mini Implantable Pulse Generator (IPG) Model 65-3788 and Eon Mini Charging System Model 3721 2014-12-10 Australia DHTGA
Recall 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 2015-08-20 Australia DHTGA
Recall of Eon, Eon Mini and Brio Implantable Pulse Generator (IPG) (Implantable Spinal Cord and Deep Brain Stimulators) 2012-08-09 Australia DHTGA
Recall of Eon Mini and Brio Implantable Pulse Generators (IPG) (Implantable Spinal Cord and Deep Brain Stimulators) 2012-08-03 Australia DHTGA
Recall of Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra(Implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices) 2016-10-11 Australia DHTGA
Recall of AGA Medical Amplatzer Septal Occluder Amplatzer Septal Occluder, 28mm 2014-06-03 Australia DHTGA
Recall of St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs) 2014-08-18 Australia DHTGA
Recall of Eon/Eon C/ Eon Mini/ Prodigy Neurostimulation Systems and Octrode/ Quattrode Percutaneous Leads and Accessories 2014-12-10 Australia DHTGA
Recall 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 2014-12-19 Australia DHTGA
Recall of Eon Wall Charger Model 3701 and Eon Portable Charger 2015-05-29 Australia DHTGA
Recall of SJM Confirm External Patient Activator Model DM2100ASupplied separately or together with a SJM Confirm Implantable Cardiac Monitor (ICM) DM2100 or DM2102 2013-04-15 Australia DHTGA
Safety Alert for Product Name: EON MINI NEUROSTIMULATION SYSTEM Technical Name: EON MINI NEUROSTIMULATION SYSTEM ANVISA Registration Number: 10332340246 Hazard Class: IV Hazard Class: 3788 2017-02-02 Brazil ANVISA
Safety Alert for The Field Action affects five products registered in Brazil. FORTIFY ™ - Registration 10332340305. UNIFY - Registration 10332340299. Fortify Assura VR - Registration 10332340358. Unify Assura - Registration 10332340344. Implantable Cardioverter and Defibrillator Quadra Assura - Record 10332340343 2016-10-24 Brazil ANVISA
Safety Alert for Business Name: HeartMate 3 - Left Ventricular Assist System. Technical Name: Other Cardiovascular Implants. ANVISA registration number: 10332340428. Class of risk: IV. Affected Model: HeartMate 3. Serial Numbers Affected: Model: 10010167 - Series Numbers: MLP-009201; MLP-009203; MLP-009205, MLP-009206; MLP-009207; MLP-009667 2018-04-17 Brazil ANVISA
Safety Alert for Implantable Defibrillator Software:. EPIC HF V-339. EPIC + V-196. EPIC + V-236. EPIC + HF V-350. ATLAS + V-193. ATLAS + V-243. ATLAS + HF V-341. ATLAS + II V-268 2008-01-28 Brazil ANVISA
Safety Alert for Implantable Defibrillator (Photon DR V-230), Registry 10332340083; Implantable Defibrillator (Photon DR V-232), Register 10332340090 Implantable Defibrillator (Photon VR V-194), Registry 10332340092, Implantable Cardioverter Defibrillator (Atlas DR V-240 V-199), Register 10332340093. 2005-10-25 Brazil ANVISA
Safety Alert for ACCORDING TO THE ANNEX List .... 2011-02-24 Brazil ANVISA
Recall of 1500T14 CARDIAC ABLATION SYSTEM - GENERATOR 2011-05-09 Canada HC
Recall of NANOSTIM LEADLESS PACEMAKER NANOSTIM DELIVERY SYSTEM CATHETER 2016-10-24 Canada HC
Recall of FORTIFY ASSURA DR 2016-10-10 Canada HC
Recall of PORT-A-CATH II DUAL LUMEN SYSTEM 2013-09-06 Canada HC