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Name Date Date initiated Country Source
Recall Or Safety Alert for NanostimTM wireless cardiac pacemaker, model S1DLCP 2016-11-02 Spain AEMPSVFOI
Recall Or Safety Alert for "Portico ™ transcatheter transcatheter transcatheter aortic valve implantation system", models PRT-23 and PRT-25 2015-03-24 Spain AEMPSVFOI
Recall Or Safety Alert for Implantable Automatic Defibrillators (DAIs) EllipseTM VR / DR, models CD1411-36Q, CD1411-36C, CD2411-36Q, CD2411-36C, CD1377-36QC, CD1377-36C, CD2377-36QC and CD2377-36C 2016-04-12 Spain AEMPSVFOI
Recall Or Safety Alert for NanostimTM wireless cardiac pacemaker, model S1DLCP and "Nanostim Programmer Link" 2017-02-16 Spain AEMPSVFOI
Recall Or Safety Alert for "NanostimTM Wireless Pacemaker & Placement System Catheter", model S1DLCP 2015-03-03 Spain AEMPSVFOI
Recall Or Safety Alert for Implantable pulse generators Brio ™ 2012-04-17 Spain AEMPSVFOI
Recall Or Safety Alert for Fortified ™ Implantable Cardioverter Defibrillators, FortifyAssura ™, QuadraAssura ™, QuadraAssura MP ™, Unify ™, UnifyAssura ™ and UnifyQuadra ™ 2016-10-19 Spain AEMPSVFOI
Recall Or Safety Alert for Merlin @ Home ™ Model EX2000 Software for the Merlin @ Home ™ Transmitter, EX1150, EX1150W, EX1100, and EX1100W 2017-04-12 Spain AEMPSVFOI
Recall Or Safety Alert for "Portico ™ Transcatheter Transcatheter Transcatheter Valve Transfemoral Implantation System" 2014-10-08 Spain AEMPSVFOI
Recall Or Safety Alert for 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 2012-01-05 Spain AEMPSVFOI
Recall Or Safety Alert for "NanostimTM Wireless Pacemaker & Placement System Catheter", model S1DLCP 2014-08-04 Spain AEMPSVFOI
Recall Or Safety Alert for Defibrillators (ICDs) and implantable pacemakers with radiofrequency (RF) capability 2015-08-19 Spain AEMPSVFOI
Recall Or Safety Alert for "NanostimTM Wireless Pacemaker & Placement System Catheter", model S1DLCP 2015-07-16 Spain AEMPSVFOI
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 (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 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 ACCORDING TO THE ANNEX List .... 2011-02-24 Brazil ANVISA
Field Safety Notices about Ellipse DR, VR 2014-08-19 Serbia ALIMSA
Field Safety Notices about EP-4 Computerised Cardiac Stimulator 2009-04-20 Germany BAM
Field Safety Notices about Livewire TC 2008-06-26 Germany BAM
Field Safety Notices about Epicor UltraWand LP Handheld Ablation device 2009-12-04 Germany BAM
Field Safety Notices about AMPLATZER™ Septal Occluder 2014-01-02 Germany BAM
Field Safety Notices about Epic, Atlas and Convert 2008-01-18 Germany BAM