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  • Device 27
  • Manufacturer 92
  • Event 253
  • Implant 4
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
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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.