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Manufacturers
LivaNova Australia Pty Ltd
Manufacturer Parent Company (2017)
LivaNova PLC
Source
DHTGA
9 Events
Recall of Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices)
Recall of Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
Recall of FlexTherm Heater Cooler Device
Recall of Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
Recall of Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
Recall of Sorin Group perfusion system – Heater Cooler 3T devices
Recall of Sorin Group perfusion system – Heater Cooler 1T devices
Recall of CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017
Recall of Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)
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9 devices in the database
Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater...
Model / Serial
Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices)D632 Adult Open System Bracket Catalogue Number: 05046Adult Oxy module Avant Bracket Catalogue Number: 050128Synthesis “C” BracketCatalogue Number: 050350Synergy Bracket Catalogue Number: 050131D626 Avant Holder Catalogue Number: 05040D630 Avant Holder Catalogue Number: 05041Synthesis Oxygenator Holder Catalogue Number: 050127ARTG # 194514
Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
Model / Serial
Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)Perceval Sutureless Heart Valve size SItem Number: ICV1208Reference: PVS21Perceval Sutureless Heart Valve size MItem Number: ICV1209Reference: PVS23Perceval Sutureless Heart Valve size LItem Number: ICV1210Reference: PVS25Perceval Sutureless Heart Valve size XLItem Number: ICV1211Reference: PVS27ARTG Number: 232485
Product Classification
Cardiovascular Devices
FlexTherm Heater Cooler Device
Model / Serial
FlexTherm Heater Cooler DeviceProduct Code: 16-70-00Affected Serial Number in Australia: 16E01091ARTG Number: 194514
Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardi...
Model / Serial
Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Ovatio - CRT 6750, DR 6550, VR 6250Previous ARTG #: 132650, 132586, 132649 Paradym - VR 8250, DR 8550, CRT-D 8750ARTG #: 170105, 170104, 163470,Paradym RF - VR 9250, DR 9550, CRT-D 975, SonR 9770 ARTG #: 197571, 197572, 197573, 197574Intensia - VR 124, DR 154, CRT-D 174, SonR CRT-D 184ARTG #: 230583, 230582, 230580, 230581
Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibri...
Model / Serial
Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Platinium VR 1210Platinium VR 1240Platinium DR 1510Platinium DR 1540Platinium CRT-D 1711Platinium CRT-D 1741Platinium SONR CRT-D 1811Platinium SONR CRT-D 1841ARTG Numbers: 282817, 282816, 282818, 282819, 282820, 282821, 282822 and 282823
4 more
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